State of Iowa Board of Pharmacy

State of Iowa

Board of Pharmacy

400 S.W. Eighth Street, Suite E, Des Moines, IA 50309-4688 https://pharmacy.iowa.gov/

Telephone: (515)281-5944 Facsimile: (515)281-4609

BOARD MEMBERS SHARON MEYER BOARD MEMBERS LADONNA GRATIAS Board Chair JASON HANSEL

EDWARD McKENNA BRETT BARKER

GAYLE MAYER ANDREW FUNK JOAN SKOGSTROM Executive Director

M I N U T E S

November 14, 2018

The Iowa Board of Pharmacy met on Wednesday, November 14, 2018, in the conference room at

400 SW Eighth Street, Des Moines, Iowa.

WEDNESDAY, NOVEMBER 14, 2018

MEMBERS PRESENT

Sharon K. Meyer, Chair

Edward McKenna, Vice-chair

Brett Barker

LaDonna Gratias

Jason Hansel

Gayle Mayer

Joan Skogstrom

SPEAKERS

T.J. Johnsrud, NuCara

Molly Driscoll, Hy-Vee

Jon Fransen, Hy-Vee

Casey Ficek, IPA

Kate Gainer, IPA

Michael Andreski, Drake University

Cheri Schmit, NuCara

STAFF PRESENT

Andrew Funk, Executive Director

Laura Steffensmeier, Esq., Assistant Attorney General

Therese Witkowski, Executive Officer

Amanda Woltz, Administrative Assistant

Jennifer Tiffany, Associate Director - PMP

Christie Carlson, Compliance Officer

Curtis Gerhold, Compliance Officer

Mark Mather, Compliance Officer

Sue Mears, Compliance Officer

Jennifer O’Toole, Compliance Officer

Jean Rhodes, Compliance Officer

Daniel Sedlacek, Compliance Officer

James Wolfe, Compliance Officer

Call to Order and Announcements

At 9:00 a.m., Sharon K. Meyer, Chair, called the meeting of the Iowa Board of Pharmacy to order

on Wednesday, November 14, 2018.

https://pharmacy.iowa.gov/

November 14, 2018 Page 2 of 20

Public Comments

There were no public comments.

Approval of Open Session Minutes

The open session minutes of the September 18, 2018, Open Session Meeting were reviewed.

Motion by Brett Barker, second by Jason Hansel, to approve the Open Session Minutes of the

September 18, 2018, meeting as presented. Motion approved unanimously.

Requests

1. Request to Waive requirement that Managing Pharmacy PIC serve as Telepharmacy PIC

– 657 I.A.C. 13, “Telepharmacy Practice” – Hy-Vee Resslers Clinic, Laurens.

Request for waiver was withdrawn by Hy-Vee.

Reports

1. Executive Director’s Report

A. Appointments – the Certified Pharmacy Technician Board member position is still

vacant and the Governor’s office is actively seeking to fill this position soon. Board

members Sharon Meyer’s and Joan Skogstrom’s appointments will be up for renewal in

2019. Terry Witkowski was nominated to serve on the Bylaws and Resolutions Committee

for the National Association of State Controlled Substance Authorities (NASCSA) for

2019.

B. Staffing – two temporary clerk specialists will be assisting Board staff through March,

2019 with licensing. The four health boards will be moving forward with sharing an in-

house human resources professional.

C. Licensing – Due to the timing of rule making for wholesaler, limited distributor, and

third-party logistics provider licenses, all current wholesaler licenses will be

administratively extended to a March 31, 2019 expiration to allow for adequate time to

apply for the appropriate license. Renewal applications for Pharmacy Support Persons,

Technicians, Controlled Substances Act registrations, Pharmacies, Wholesalers, and

Outsourcing Facilities have been updated and are available on the Board’s website.

D. Database – all remaining renewal applications have now gone live on the database as of

November 1, 2018. Online new applications will be implemented in spring 2019.

Automated notifications will be implemented on December 1 and will provide multiple

reminders for renewal until renewal is processed. A systems change will be sought to match

a technician’s registration expiration with the expiration of the technician’s national

certification. A similar change will be sought for CSA registration to match the underlying

professional license expiration.

Meetings and Travel

A. National Association of Boards of Pharmacy (NABP) Interactive Member Forum

November 28-29, 2018 – Jason Hansel will attend.


B. ASHP Clinical Midyear December 2-6, 2018 – Sharon Meyer will attend.

C. Next Board meeting is scheduled for January 8-9, 2019 in Des Moines.

2. Iowa Pharmaceutical Collection and Disposal – Drug Enforcement Administration

(DEA) Compliant Collection Receptacles – Jennifer Tiffany.

Jennifer Tiffany provided the Board with an update including that approximately 1,000

pounds of controlled substances per month have been destroyed, there have been 13 new

units placed in pharmacies, and there are 32 sites wanting a collection receptacle.

3. Iowa Prescription Monitoring Program – Jennifer Tiffany.

Jennifer Tiffany provided the Board with an update including that the PMP Advisory

Council met in October and discussed potential legislative initiatives and set the threshold

for proactive notifications to activate when a patient has visited at least four pharmacies or

four prescribers within 60 days; PMP staff continue to engage registrants with education

and outreach; and the required annual prescriber report cards will be initiated in February

and will be distributed quarterly.

4. Iowa Monitoring Program for Pharmacy Professionals (IMP3) – Jennifer O’Toole.

Jennifer O’Toole provided an update to the Board with current participation in the program

and that 37 licensees or registrants have had some level of engagement with the program.

5. Legal update – Laura Steffensmeier.

Laura Steffensmeier provided the Board with an update on one case pending in District

Court.

6. Technician Product Verification Quarterly Reports – 3rd Quarter 2018

A. NuCara Pharmacy, Lenox

B. Towncrest Pharmacy, Iowa City

C. Hy-Vee Pharmacy, Fort Dodge

D. Main at Locust Pharmacy, Davenport

E. Medicap Pharmacy, Ames

F. Medicap Pharmacy, Indianola

G. Unity Point Health Finley Hospital Pharmacy, Dubuque

H. NuCara Pharmacy, Traer

I. Mercy Family Pharmacy, Dyersville

J. Thrifty White Pharmacy, Spencer


K. Thrifty White Pharmacy, Denison

7. Hy-Vee Fulfillment Center Quarterly Report.

Jon Fransen presented a summary of the report for the Board.

8. 2018 FDA Intergovernmental Working Meeting on Drug Compounding.

Informational item.

9. SUPPORT Act – federal opioid bill signed October 2018.

Informational item.

10. NABP License Portability Report.

Informational item.

11. Iowa Pharmacy Association legislative priorities.

Casey Ficek provided the Board with a summary of the Association’s legislative priorities

for the 2019 legislative session.

12. Iowa’s Medication Disposal Program for Non-Controlled Substances Quarterly Report

for July – September 2018 - Iowa Pharmacy Association (IPA) – Kate Gainer.

Kate Gainer provided the Board with a summary of the collection program’s activities.

Proposed Comments and Discussion – USP Chapter <797>

Christie Carlson provided the Board with information relating to the current proposed revision of

USP General Chapter 797. USP is accepting comments until November 30, 2018. Ms. Carlson

presented the Board with initial suggested comments to consider submitting to USP. Comments

were also presented by T.J. Johnsrud and Kate Gainer.

Legislation

1. Proposed amendments to Iowa Code Chapter 155A.

Motion by Brett Barker, second by Jason Hansel, to make changes as discussed and file for

the 2019 legislative session. Motion approved unanimously. A copy is attached as

Addendum A.

2. Proposed amendments to Iowa Code Chapter 124.

Motion by Jason Hansel, second by Brett Barker, to file the proposed amendments as

presented for the 2019 legislative session. Motion approved unanimously. A copy is

attached as Addendum B.


Rules

1. Proposed for Adoption and Filing Amendments to Chapter 1, “Purpose and Organization”

(ARC 3977C).

Motion by Brett Barker, second by Gayle Mayer, to adopt. Motion approved unanimously.

A copy is attached as Addendum C.

2. Proposed for Adoption and Filing Amendments to Chapter 3, “Pharmacy Technicians,”

and Chapter 6, “General Pharmacy Practice” (ARC 4030C).

Motion by Brett Barker, second by Edward McKenna, to adopt. Motion approved

unanimously. A copy is attached as Addendum D.

3. Proposed for Adoption and Filing Amendments to Chapter 8, “Universal Practice

Standards” (ARC 3978C).

Motion by Jason Hansel, second by Edward McKenna, to adopt. Motion approved

unanimously. A copy is attached as Addendum E.

4. Proposed for Adoption and Filing to rescind Chapter 17, “Wholesale Drug Licenses” and

adopt new Chapter 17, “Wholesale Distributor Licenses” (ARC 3974C).

Motion by Jason Hansel, second by Gayle Mayer, to adopt. Motion approved unanimously.

A copy is attached as Addendum F.

5. Proposed for Adoption and Filing to adopt new Chapter 42, “Limited Distributor Licenses”

(ARC 3975C).

Motion by Brett Barker, second by Edward McKenna, to adopt. Motion approved

unanimously. A copy is attached as Addendum G.

6. Proposed for Adoption and Filing to adopt new Chapter 43, “Third-Party Logistics

Provider Licenses” (ARC 3976C).

Motion by Edward McKenna, second by Gayle Mayer, to adopt. Motion approved

unanimously. A copy is attached as Addendum H.

7. Proposed Notice of Intended Action to rescind Chapter 37, “Iowa Prescription Monitoring

Program” and adopt new Chapter 37, “Iowa Prescription Monitoring Program.”

Motion by Brett Barker, second by Edward McKenna, to file for Notice of Intended Action.

Motion approved unanimously. A copy is attached as Addendum I.

8. Proposed Notice of Intended Action to rescind Chapter 40, “Tech-Check-Tech Programs”

and adopt new Chapter 40, “Technician Verification Programs.”

The Board reviewed and discussed the proposed rule making. Comments were provided

by T.J. Johnsrud, Kate Gainer, Michael Andreski, and Cheri Schmit with suggestions for

changes. The Board took no action at this time.

Closed Session

At 1:10 p.m., on a motion by Jason Hansel, second by Edward McKenna, the Board voted

unanimously by roll call vote to move into closed session pursuant to Iowa Code Section


21.5(1)(a), to review or discuss records which are required or authorized by state or federal law to

be kept confidential; pursuant to Iowa Code Section 21.5(1)(d), to discuss whether to initiate

licensee disciplinary investigations or proceedings; and pursuant to Iowa Code Section 21.5(1)(f),

to discuss the decision to be rendered in a contested case conducted according to the provisions of

Iowa Code Chapter 17A.

At 4:55 p.m., while still in closed session, Brett Barker moved that the Board go into open session,

seconded by Jason Hansel. Motion approved unanimously.

In open session, the following actions were taken:

1. Closed Session Minutes.

Motion by Brett Barker, second by Edward McKenna, to approve the Closed Session

Minutes of the September 18, 2018 and September 19, 2018 meetings. Motion passed

unanimously.

2. Close With No Further Action.

Motion by Edward McKenna, second by Jason Hansel, to close with no further action the

following investigative files in complaint numbers: 2018-30, 2018-36, 2018-52, 2018-67,

2018-81, 2018-112, 2018-105, 2018-64, 2018-65, 2018-46, and 2018-17. Motion passed

unanimously.

Motion by Brett Barker, second by Edward McKenna, to close with no further action the

investigative file in complaint number 2018-100. Jason Hansel abstained. Motion passed.

3. Letter of Education.

Motion by Edward McKenna, second by Brett Barker, to issue a Letter of Education to the

pharmacist in charge and pharmacy in complaint number 2018-87, to the pharmacist in

charge in complaint number 2018-60, and the pharmacy in complaint number 2018-66.

Motion passed unanimously.

4. Administrative Warning.

Motion by Jason Hansel, second by LaDonna Gratias, to issue an Administrative Warning

to the registrant in complaint number 2018-74; to the technician, pharmacy, and pharmacist

in charge in complaint number 2018-76; to the technician and pharmacy in complaint

number 2018-121; and to the pharmacy in complaint number 2018-114. Motion passed

unanimously.

Motion by LaDonna Gratias, second by Gayle Mayer, to issue an Administrative Warning

to the pharmacist in charge in complaint number 2018-113. Brett Barker abstained. Motion

passed.

5. Settlement Agreement and Final Order.

Motion by Jason Hansel, second by Edward McKenna, to approve the Settlement

Agreement and Final Order in 2018-82, Sheila Schleeper, Pharmacist License No. 23200,

Burlington. Motion approved unanimously. A copy of the Settlement Agreement and

Final Order is attached as Addendum J.

6. Combined Statement of Charges, Settlement Agreement, and Final Order.


Motion by Brett Barker, second by Gayle Mayer, to approve the Combined Statement of

Charges, Settlement Agreement, and Final Order in the following cases. Motion approved

unanimously.

A. 2018-69, Russell England, MD, CSA Registration No. 1208110, Fairfield. A copy of

the Combined Statement of Charges, Settlement Agreement, and Final Order is

attached as Addendum K.

B. 2018-95, Tara Bevans, Pharmacy Support Person, Registration No. 5363, Waterloo. A

copy of the Combined Statement of Charges, Settlement Agreement, and Final Order

is attached as Addendum L.

At 5:00 p.m., on a motion by Brett Barker, second by Jason Hansel, the Board voted unanimously

by roll call vote to move into closed session pursuant to Iowa Code Section 21.5(1)(f), to discuss

the decision to be rendered in a contested case conducted according to the provisions of Iowa Code

Chapter 17A.

At 5:03 p.m., while still in closed session, Brett Barker moved that the Board go into open session,

seconded by Jason Hansel. Motion approved unanimously.

In open session, the following action was taken:

1. Findings of Fact, Conclusions of Law, Decision, and Order.

Motion by Brett Barker, second by Gayle Mayer, to approve the Findings of Fact,

Conclusions of Law, Decision, and Order, in case 2017-146, Christopher Betts, Pharmacist

License No. 19918, Urbandale. Motion approved unanimously. A copy of the Findings of

Fact, Conclusions of Law, Decision, and Order is attached as Addendum M.

The Board adjourned at 5:04 p.m. on November 14, 2018.

_______

Sue Mears

Recording Secretary

Andrew Funk Sharon K. Meyer

Executive Director Board Chair

APPROVED THIS 9th DAY OF JANUARY, 2019

ADDENDUM A

PROPOSED AMENDMENTS TO IOWA CODE CHAPTER 155A

NOVEMBER 14, 2018

A BILL FOR

An Act relating to the practice of pharmacy, including the administration of certain vaccines.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

Section 1. Section 155A.46, subsection 1, paragraph “c”, 2018 Iowa Acts, Senate File 2322,

section 7, is amended to read as follows:

c. A pharmacist may, pursuant to statewide protocols developed by the board in

consultation with the department of public health and consistent with subsection 2, order and

administer the final two doses in a course of vaccinations for HPV to patients ages eleven years

and older:

(1) the final two doses in a course of vaccinations for HPV (human papillomavirus).

(2) a Tdap (tetanus, diphtheria, pertussis) vaccination as required in section 139A.8,

subsection 2, paragraph “a”.

(3) a meningococcal vaccination as required in section 139A.8, subsection 2, paragraph

”e”.

Sec. 2. Section 155A.46, subsection 1, paragraph “d”, 2018 Iowa Acts, Senate File 2322, section

7, is amended to read as follows:

d. Prior to the ordering and administration of a vaccination or immunization

authorized by this subsection, pursuant to statewide protocols, a licensed pharmacist shall consult

and review the statewide immunization registry or health information network, except for

influenza or other emergency immunizations or vaccinations in response to a public health

emergency. The board shall adopt rules requiring the reporting of the administration of vaccines

and immunizations authorized by this subsection, except for influenza or other emergency

immunizations or vaccinations in response to a public health emergency, to a patient’s primary

health care provider, primary physician, and a statewide immunization registry or health

information network.

Sec. 3. Section 155A.46, 2018 Iowa Acts, Senate File 2322, section 7, is amended by adding the

following new subsection:

NEW SUBSECTION. 3. Following a pharmacist’s clinical determination of the appropriateness

of an immunization or vaccination pursuant to statewide protocols, including consultation and

review of the statewide immunization registry or health information network, unless excepted

pursuant to subsection 2, paragraph “d,” a pharmacist may delegate the technical administration

function pursuant to rules of the board.

EXPLANATION

This bill seeks to expand access to immunizations for patients eleven years and older for the Tdap (tetanus, diphtheria, pertussis) and meningococcal vaccinations. The bill restores an exception to the requirement that a pharmacist must consult and review the statewide immunization registry or health information network prior to the administration of an influenza vaccination or vaccination in response to a public health emergency or to report such administration to the statewide registry or network. The bill allows, following the pharmacist’s clinical determination of the appropriateness of an immunization or vaccination pursuant to statewide protocols, the pharmacist may delegate the technical administration function pursuant to rules of the board.

ADDENDUM B

PROPOSED AMENDMENTS TO IOWA CODE CHAPTER 124

NOVEMBER 14, 2018

A BILL FOR

An Act relating to controlled substances, adding substances to the controlled substances schedules, removing references to board rules relating to marijuana, and expanding information collection and amending reporting requirements for the Iowa Prescription Monitoring Program.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

DIVISION I

IOWA PRESCRIPTION MONITORING PROGRAM

Section 1. Section 124.554, subsection 1, paragraph g, Code 2018, is amended to read as follows:

g. Including all schedule II, schedule III, and schedule IV controlled substances, those substances in schedules III and IV that the advisory council and board determine can be addictive or fatal if not taken under the proper care and direction of a prescribing practitioner, schedule V controlled substances including when dispensed by a pharmacist without a prescription, except for sales of pseudoephedrine which are reported to the real-time electronic repository, and opioid antagonists, and other prescription substances that the advisory council and board determine can be addictive or fatal if not taken under the proper care and direction of a prescribing practitioner.

Sec. 2. Section 124.554, subsection 2, Code 2018, is amended to read as follows:

2. Beginning January February 1, 2007 2020, and annually by January February 1 thereafter, the board and advisory council shall present to the general assembly and the governor a report prepared consistent with section 124.555, subsection 3, paragraph “d”, which shall include but not be limited to the following:

a. The cost to the state of implementing and maintaining the program.

b. Information from pharmacies, prescribing practitioners, the board, the advisory council, and others regarding the benefits or detriments of the program.

c. Information from pharmacies, prescribing practitioners, the board, the advisory council, and others regarding the board’s effectiveness in providing information from the program.

DIVISION II

Commented [S1]: Updates PMP reporting to include all CV substances and other Rx drugs deemed appropriate by IBOP/PMP AC

Commented [S2]: Changes annual report due date

CHANGES AND ADDITIONS TO CONTROLLED SUBSTANCES SCHEDULES

Sec. 3. Section 124.204, subsection 2, Code 2018, is amended by adding the following new paragraph:

NEW PARAGRAPH: be. MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine).

Sec. 4. Section 124.204, subsection 4, paragraph “m”, Code 2018, is amended to read as follows:

m. Marijuana, except as otherwise provided by rules of the board for medicinal purposes.

Sec. 5. Section 124.204, subsection 4, paragraph “u”, Code 2018, is amended to read as follows:

u. Tetrahydrocannabinols, except as otherwise provided by rules of the board for medicinal purposes, meaning tetrahydrocannabinols naturally contained in a plant of the genus Cannabis (Cannabis plant) as well as synthetic equivalents of the substances contained in the Cannabis plant, or in the resinous extractives of such plant, and synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plan, such as the following:

(1) 1 cis or trans tetrahydrocannabinol, and their optical isomers.

(2) 6 cis or trans tetrahydrocannabinol, and their optical isomers.

(3) 3,4 cis or trans tetrahydrocannabinol, and their optical isomers. (Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)

Sec. 6. Section 124.204, subsection 6, paragraph “i”, Code 2018, is amended by adding the following new subparagraph:

NEW SUBPARAGRAPH: (27) 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one. Other names: N-ethylpentylone or ephylone.

Sec. 7. Section 124.204, subsection 7, Code 2018, is amended by striking the subsection.

Sec. 8. Section 124.204, subsection 9, Code 2018, is amended by adding the following new paragraphs:

NEW PARAGRAPH: af. N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters, and ethers. Other name: cyclopropyl fentanyl.

Commented [S3]: Adds this opioid analgesic to CI

Commented [S4]: Removes language related to “rules of the board” for medicinal marijuana programs

Commented [S5]: Removes language related to “rules of the board” for medicinal marijuana programs

Commented [S6]: Adds one synthetic cathinone to CI

Commented [S7]: Removes language related to medical marijuana programs by the board

Commented [S8]: Adds 5 synthetic cannabinoids and 9 synthetic opioids to CI

NEW PARAGRAPH. ag. N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers. Other name: valeryl fentanyl.

NEW PARAGRAPH. ah. N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers. Other name: para-fluorobutyryl fentanyl.

NEW PARAGRAPH. ai. N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butryamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers. Other name: para-methyoxybutyryl fentanyl.

NEW PARAGRAPH. aj. N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutryramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers. Other name: para-chloroisobutyryl fentanyl.

NEW PARAGRAPH. ak. N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers. Other name: isobutyryl fentanyl.

NEW PARAGRAPH. al. N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers. Other name: cyclopentyl fentanyl.

NEW PARAGRAPH. am. N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers. Other name: ocfentanil.

NEW PARAGRAPH. an. Fentanyl-related substances, their isomers, esters, ethers, salts and salts of isomers, esters and ethers.

(1) Fentanyl related substance means any substance not otherwise listed under another schedule, and for which no exemption or approval is in effect under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is structurally related to fentanyl by one or more of the following modifications:

a. Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;

b. Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;

c. Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;

d. Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or

e. Replacement of the N-propionyl group by another acyl group.

(2) This definition includes, but is not limited to, the following substances: a. Reserved. b. Reserved.

NEW PARAGRAPH. ao. Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate. Other names: NM2201 or CBL2201.

NEW PARAGRAPH. ap. N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide. Other name: 5F-AB-PINACA.

NEW PARAGRAPH. aq. 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide. Other names: 4-CN-CUMYL-BUTINACA, 4-cyano-CUMYL-BUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-BINACA, or SGT-78. NEW PARAGRAPH. ar. Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate. Other names: MMB-CHMICA or AMB-CHMICA.

NEW PARAGRAPH. as. 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide. Other name: 5F-CUMYL-P7AICA.

Sec. 9. Section 124.206, subsection 7, paragraph “a”, Code 2018 is amended by striking the paragraph.

Sec. 10. Section 124.208, subsection 3, paragraph “c”, Code 2018, is amended to read as follows:

c. Any substance which contains any quantity of a derivative of barbituric acid or any salt thereof (including, but not limited to, Fioricet).

Sec. 11. Section 124.212, Code 2018, is amended by adding the following new subsection: NEW SUBSECTION: 6. Approved cannabidiol drugs. A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

Sec. 12. EFFECTIVE DATE. This division of this Act, being deemed of immediate importance, takes effect upon enactment.

EXPLANATION

DIVISION I. This division of the bill seeks to expand reporting to the Iowa prescription monitoring program (PMP) to include those controlled substances in schedule V of the Iowa Uniform Controlled Substances Act which are dispensed to patients in Iowa. The reporting requirement would include all schedule V controlled substances, including those which do not require a prescription to be dispensed by a pharmacist but excluding the sale of pseudoephedrine

Commented [S9]: Removes language related to medical marijuana programs by the board

Commented [S10]: Makes all butalbital products (even if identified on DEA Exempted Prescription List) CIII products (subject to PMP reporting)

Commented [S11]: Schedules Epidiolex as CV

Commented [S12]: Immediate effectiveness upon enactment

products which sales are reported to the real-time electronic repository. The reporting requirement would also include other prescription substances that the PMP advisory council and the board determine could be addictive or fatal if not taken under the proper care and direction of a prescribing practitioner.

The bill also changes the due date for annual reports to the governor and the legislature regarding the program from January 1 to February 1 to provide complete annual data in each annual report.

DIVISION II. This bill of the bill adds one opioid analgesic, one synthetic cathinone, five synthetic cannabinoids, and nine synthetic opioids to schedule I of the Controlled Substances Act. The bill adds to schedule V of the Act any FDA-approved products containing cannabidiol (CBD) that contain no more than 0.1 percent tetrahydrocannabinols (THC). These scheduling actions follow similar scheduling action taken by the federal Drug Enforcement Administration (DEA).

The bill designates all products which contain derivatives of barbituric acid (butalbital) as schedule III controlled substances, subject to reporting to the PMP. Currently, DEA exempts some butalbital-containing products from all controlled schedules, but the PMP advisory council and board consider these products potentially addictive and seek to include usage of these substances in PMP data for practitioner evaluation.

The bill seeks to remove language referring to “rules of the board” relating to medical marijuana programs since it has no such programs.

ADDENDUM C

ADOPTION AND FILING

AMENDING CHAPTER 1, “PURPOSE AND ORGANIZATION”

NOVEMBER 14, 2018

1

PHARMACY BOARD [657]

Adopted and Filed

The Board of Pharmacy hereby amends Chapter 1, “Purpose and Organization,” Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 155A.13C.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code sections 147.14, 147.19, 155A.2A, 155A.3 and 155A.13C and 2018 Iowa Acts, Senate File 2298.

Purpose and Summary

During the 2017 and 2018 sessions of the 87th General Assembly, changes were made to the Iowa Code to allow the Board to designate a pool of up to seven alternate board members, subject to approval by the Governor, to hear contested case hearings when needed; add a Certified Pharmacy Technician to the composition of the Board; update the definitions of wholesale distributors and limited distributors; and define third-party logistics providers. The amendments incorporate language to implement the changes that were made to the Iowa Code and provide general clerical updates where appropriate.

Public Comment and Changes to Rule Making

Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on August 29, 2018, as ARC 3977C. The Board received one comment from the Iowa Pharmacy Association in support of the amendments and encourages the Board to consider members who are reflective of the diverse practice settings pharmacists occupy when determining the list of eligible individuals serving in the alternate pool. The amendments are identical to those published for Notice.

Adoption of Rule Making

This rule making was adopted by the Board on ______, 2018. Fiscal Impact

This rule making has no fiscal impact to the State of Iowa. Jobs Impact

After analysis and review of this rule making, no impact on jobs has been found. Waivers

2

Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

Effective Date

This rule making will become effective on _______, 2019. The following rule-making actions are adopted:

ITEM 1. Amend rule 657—1.2(17A,147,272C) as follows:

657—1.2(17A,147,155A,272C) Description and organization of board. The board is comprised of five pharmacist members, one certified pharmacy technician member, and two representatives of the general public, all appointed by the governor. An administrative staff headed by a board-appointed executive director assists board members.

The board’s authority for regulating the practice of pharmacy and the legal distribution and dispensing of prescription drugs and devices and of precursor substances in the state of Iowa is found in Iowa Code chapters 124, 124B, 126, 147, 155A, 205, and 272C.

ITEM 2. Amend rule 657—1.3(17A,272C) as follows:

657—1.3(17A,272C) Responsibilities. The responsibilities of the board include but are not limited to: 1. and 2. No change. 3. Regulating the legal distribution of prescription drugs through the licensing of pharmacies and wholesalers, wholesale distributors, limited distributors, outsourcing facilities, and third-party logistics providers under the authority of Iowa Code chapter 155A. 4. to 8. No change. 9. Instituting disciplinary actions, hearing contested cases, issuing decisions and orders, and enforcing the terms of disciplinary orders filed against licensees, registrants, or permit holders for grounds provided in Iowa Code sections 124.303, 124.304, 124B.12, 147.55, 155A.6, 155A.6A, 155A.6B, 155A.12, 155A.13, 155A.13A, 155A.15, and 155A.17, and 155A.42 and 2018 Iowa Acts, Senate File 2298, as appropriate. 10. No change. 11. Registering pharmacists in charge of nonresident pharmacies pursuant to the authority of Iowa Code chapter 155A.

ITEM 3. Amend rule 657—1.4(17A,272C) as follows:

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657—1.4(17A,272C) Submission of complaints and requests. Members of the general public may obtain information or submit requests or complaints relative to the practice of pharmacy, continuing education for pharmacists, the legal distribution and dispensing of prescription drugs, or any other matters relating to the function and authority of the board. Correspondence should be submitted to the Executive Director, Board of Pharmacy, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688. Communication may also be submitted via the board’s website at www.state.ia.us/ibpe pharmacy.iowa.gov.

ITEM 4. Amend rule 657—1.5(17A,21) as follows:

657—1.5(17A,21) Meetings. All meetings of the board shall be open and public, and all members of the public shall be permitted to attend any meeting unless Iowa Code section 21.5 or another provision of law authorizes a closed session. Closed session shall only be by affirmative public vote of either two-thirds of the members of the board or all of the members present at the meeting. 1.5(1) No change. 1.5(2) Meeting schedule and public notice. The board shall set the dates of its meetings at the first meeting following May 1 of each fiscal year. Notices of meetings shall be routinely posted in the space set aside for that purpose in the office of the board and on the board’s website at www.state.ia.us/ibpe pharmacy.iowa.gov. Members of the general public may obtain the dates, times, and locations of board meetings by submitting a request to the Executive Director, Board of Pharmacy, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688, or by accessing the board’s website. 1.5(3) No change. 1.5(4) Minutes of meetings. The executive secretary director shall keep a record of all minutes of the board, and these minutes, except as otherwise provided by statute, shall be open to the public for inspection. 1.5(5) No change.

Rules 657—1.1(17A) through 657—1.5(17A,21) are intended to implement Iowa Code sections 17A.3, 21.3 through 21.5, 124.301, 147.14, 147.76, 155A.2, 272C.3, and 272C.4.

ITEM 5. Amend rule 657—1.6(124,147,155A) as follows:

657—1.6(124,147,155A) Fee for returned check. A nonrefundable fee of $20 may be charged for a check returned for any reason. If a license, registration, or permit has been issued by the board office based on a check for the payment of fees and the check is later returned by the bank, the board shall request payment by certified check, cashier’s check, or money order. If the fees, including the fee for a returned check, are not paid within 15 calendar days of notification of the returned check, the license, registration, or permit is no longer in effect and the status reverts to what it would have been had the license, registration, or permit not been issued. Late payment penalties will be assessed, as provided in board rules, for subsequent requests to renew or reissue the license, registration, or permit.

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ITEM 6. Adopt the following new rule 657—1.8(155A):

657—1.8(155A) Alternate board members. The board may have a pool of up to seven alternate members, to include individuals who may or may not be licensed to practice under Iowa Code chapter 155A, to substitute for board members unable to participate in a contested case hearing. Utilization of such alternate board members shall be in compliance with Iowa Code section 155A.2A. Whenever there are fewer than seven individuals serving in the pool of alternate board members, the executive director may present to the board for approval a list of individuals eligible to serve in the pool. The board may select individuals to serve as alternate board members, subject to approval by the governor. The term of each alternate board member shall begin on the first day of the month following approval by the governor and shall last for three years or until the alternate board member resigns, whichever occurs first. An alternate board member may serve no more than nine years as an alternate board member. Upon approval by the governor of an alternate board member, the executive director may select that alternate board member to hear a contested case when a sufficient number of board members are unavailable to hear a contested case for any reason.

ITEM 7. Amend 657—Chapter 1, implementation sentence, as follows: These rules are intended to implement Iowa Code sections 17A.3, 21.3 through 21.5,

124.301, 124B.11, 147.14, 147.76, 147.96, 155A.2, 155A.2A, 155A.6, 155A.6A, 155A.6B, 155A.11, 155A.13, 155A.13A, 155A.13C, 155A.14, and 155A.15, 155A.17, 155A.42, 272C.3, and 272C.4 and 2018 Iowa Acts, Senate File 2298.

ADDENDUM D

ADOPTION AND FILING

AMENDING CHAPTER 3, “PHARMACY TECHNICIANS,” AND CHAPTER 6, “GENERAL PHARMACY PRACTICE”

NOVEMBER 14, 2018

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Adopted and Filed

The Pharmacy Board hereby amends Chapter 3, “Pharmacy Technicians,” and Chapter 6, “General Pharmacy Practice,” Iowa Administrative Code.


This rule making is adopted under the authority provided in Iowa Code sections 147.76, 155A.6A, 155A.33, and 155A.34.


This rule making implements, in whole or in part, Iowa Code sections 155A.6A and 155A.33 and 2018 Iowa Acts, Senate File 2322.

Purpose and Summary

The amendments allow a certified pharmacy technician to transfer a prescription for a noncontrolled substance to another pharmacy or receive a prescription transfer for a noncontrolled substance from another pharmacy, allow a technician to dispense a verified prescription which has been deemed to not require counseling to a patient while the pharmacist is on a break, and simplify rule language relating to the electronic transfer of prescriptions in anticipation of enhanced technologies in pharmacy software system capabilities.

2018 Iowa Acts, Senate File 2322, section 6, amended the Iowa Code during the 2018 Legislative Session to provide for the transfer of prescriptions between licensed pharmacies in accordance with Board rules. Electronic systems, technician training, and pharmacist oversight provide sufficient safeguards to ensure certified technicians are capable of transmitting such prescription information.

Pharmacists often find it difficult to take a rest or lunch break due, in part, to technicians being prohibited from dispensing a prescription when the pharmacist is away from the immediate dispensing area. These amendments allow a technician, at the discretion of the on-duty supervising pharmacist and pursuant to policies and procedures, to dispense a verified prescription which has been deemed to not require counseling to a patient when the pharmacist is absent from the pharmacy department on a break of limited duration.


Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on September 26, 2018, as ARC 4030C. The Board received one comment from the Iowa Pharmacy Association in support of the amendments. The amendments are identical to those published for Notice.


This rule making was adopted by the Board on ________, 2018.

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Fiscal Impact

This rule making has no fiscal impact to the state of Iowa. Jobs Impact

After analysis and review of this rule making, no impact on jobs can be determined. Waivers




Effective Date

This rule making will become effective on ______, 2019. The following rule-making actions are adopted:

ITEM 1. Amend rule 657—3.21(155A) as follows:

657—3.21(155A) Delegation of functions. 3.21(1) Technical dispensing functions. A pharmacist may delegate technical dispensing functions to an appropriately trained and registered pharmacy technician, but only if the pharmacist is on site and available to supervise the pharmacy technician when delegated functions are performed, except as provided in 657—subrule 6.7(2) rule 657—6.7(124,155A) or 657—subrule 7.6(2) 657—7.6(155A), as appropriate, or as provided for telepharmacy in 657—Chapter 9 657—Chapter 13. Except as provided for an approved tech-check-tech program pursuant to 657—Chapter 40, the pharmacist shall provide and document the final verification for the accuracy, validity, completeness, and appropriateness of the patient’s prescription or medication order prior to the delivery of the medication to the patient or the patient’s representative. A pharmacy technician shall not delegate technical functions to a pharmacy support person. 3.21(2) Nontechnical functions. A pharmacist may delegate nontechnical functions to a pharmacy technician or a pharmacy support person only if the pharmacist is present to supervise the pharmacy technician or pharmacy support person when delegated nontechnical functions are performed, except as provided in 657—subrule 6.7(2) rule 657—6.7(124,155A) or 657—subrule 7.6(2) 657—7.6(155A), as appropriate, or as provided for telepharmacy in 657—Chapter 9 657—Chapter 13.

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ITEM 2. Adopt the following new paragraphs 3.22(1)“k” and “l”: k. Transfer via oral, facsimile, or electronic means the original prescription drug order information and prescription refill information of a prescription for a noncontrolled substance to a pharmacy as requested by a patient or patient’s caregiver pursuant to rule 657—6.9(124,155A). A technician shall not transfer by any means the original prescription drug order information or prescription refill information for a controlled substance. l. Receive via oral, facsimile, or electronic means the transfer of original prescription drug order information and prescription refill information of a prescription for a noncontrolled substance from a pharmacy as requested by a patient or patient’s caregiver pursuant to rule 657—6.9(124,155A). A technician shall not receive via transfer by any means the original prescription drug order information or prescription refill information of a prescription for a controlled substance.

ITEM 3. Amend rule 657—3.23(155A) as follows:

657—3.23(155A) Tasks a pharmacy technician shall not perform. A pharmacy technician shall not be authorized to perform any of the following judgmental tasks: 1. to 4. No change. 5. Transfer a prescription drug order for a controlled substance to another pharmacy or receive the transfer of a prescription drug order for a controlled substance from another pharmacy; 6. No change.

ITEM 4. Amend subrule 6.7(1) as follows: 6.7(1) Department locked. The prescription department shall be locked by key or combination so as to prevent access when a pharmacist is not on site except as provided in subrule subrules 6.7(2)and 6.7(4).

ITEM 5. Adopt the following new subrule 6.7(4): 6.7(4) Refill sales during pharmacist break. At the discretion of the on-duty supervising pharmacist and pursuant to established policies and procedures, the pharmacist may delegate to a technician the dispensing of previously verified prescriptions which have been identified to not require pharmacist counseling pursuant to rule 657—6.14(155A) when the pharmacist is on a break of limited duration and is absent from the pharmacy department.

ITEM 6. Amend rule 657—6.9(124,155A) as follows:

657—6.9(124,155A) Transfer of prescription. The transmission of a prescription drug order from a pharmacy to a pharmacy engaged in centralized prescription filling or processing on behalf of the originating pharmacy pursuant to the requirements of 657—Chapter 18 shall not constitute the transfer of a prescription. Upon the request of a patient or the patient’s caregiver, a pharmacy shall transfer original prescription drug order information and prescription refill information to a pharmacy designated by the patient or the patient’s caregiver, central fill or processing pharmacies excepted, subject to the following requirements:

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6.9(1) and 6.9(2) No change. 6.9(3) Communication Authorized individuals and means of transmission. The transfer is communicated directly between pharmacists, directly between pharmacist-interns under the direct supervision of pharmacists at the respective pharmacies, directly between a pharmacist and a pharmacist-intern under the direct supervision of a pharmacist, or as authorized in subrule 6.9(8). Following direct communication between authorized individuals as provided herein, the Individuals authorized to engage in the transfer of prescriptions include a pharmacist, a pharmacist-intern under the direct supervision of a pharmacist, and a certified pharmacy technician only as authorized in rule 657—3.22(155A). The transferring pharmacist or pharmacist-intern individual may transmit the prescription and transfer information required under subrule 6.9(5) from the transferring pharmacy via electronic means pursuant to subrule 6.9(8) or, following direct communication between authorized individuals, via oral or facsimile transmission. The receiving pharmacist or pharmacist-intern individual shall ensure the prescription transfer record maintained in the receiving pharmacy contains all of the information required under subrule 6.9(7). 6.9(4) No change. 6.9(5) Record of transfer out. The pharmacist or pharmacist-intern individual transferring the prescription drug order information shall: a. Invalidate the prescription drug order; b. Record on or with the invalidated prescription drug order the following information: (1) The name, address, and, for a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred; (2) The name of the pharmacist or pharmacist-intern individual receiving the prescription drug order information; (3) The name of the pharmacist or pharmacist-intern individual transferring the prescription drug order information; and (4) The date of the transfer. 6.9(6) No change. 6.9(7) Record of transfer received. The pharmacist or pharmacist-intern individual receiving the transferred prescription drug order information shall: a. Indicate that the prescription drug order has been transferred; b. Record on or with the transferred prescription drug order the following information: (1) to (5) No change. (6) Name of the pharmacist or pharmacist-intern individual receiving the prescription drug order information; (7) Name of the pharmacist or pharmacist-intern individual transferring the prescription drug order information; and (8) No change. 6.9(8) Electronic transfer between pharmacies. Pharmacies electronically accessing the same prescription drug order records via a real-time, online database may electronically transfer

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prescription information, including controlled substance prescription information , up to the maximum refills permitted by law and the prescriber’s authorization, if the following requirements are met in compliance with federal regulations for controlled substances. For transfers of prescriptions for noncontrolled substances and controlled substances, pharmacies that share a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. A prescription for a controlled substance transferred between two pharmacies which do not share a real-time, online database may only be transferred one time. a. The data processing system shall have a mechanism to send the transferring pharmacy a message containing the following information: (1) The fact that the prescription drug order was transferred; (2) The unique identification number of the prescription drug order transferred; (3) The name, address, and DEA registration number of the pharmacy to which the prescription drug order was transferred and the name of the pharmacist or pharmacist-intern receiving the prescription information; and (4) The date and time of transfer. b. A pharmacist or pharmacist-intern under the direct supervision of a pharmacist in the transferring pharmacy shall review the message and document the review by signing and dating a hard copy of the message or logbook containing the information required on the message, or by a notation in the electronic message that includes the unique identification of the pharmacist or pharmacist-intern and the date of review, as soon as practical, but in no event more than 72 hours from the time of such transfer. c. For transfers of controlled substance prescriptions, all information requirements included in subrules 6.9(1) and 6.9(3) through 6.9(7) shall be satisfied in the electronic system. Transfers of controlled substance prescriptions shall also identify the pharmacy name, address, DEA registration number, and prescription number from which the prescription was originally filled.

ADDENDUM E

ADOPTION AND FILING

AMENDING CHAPTER 8, “UNIVERSAL PRACTICE STANDARDS”

NOVEMBER 14, 2018

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Adopted and Filed

The Board of Pharmacy hereby amends Chapter 8, “Universal Practice Standards,” Iowa Administrative Code.


This rule making is adopted under the authority provided in Iowa Code sections 147.76, 155A.2 and 155A.13.


This rule making implements, in whole or in part, Iowa Code sections 155A.2 and 155A.13.

Purpose and Summary

The United States Pharmacopeial Convention (USP) establishes national minimum standards for a number of health care related topics. USP General Chapter 800, enforceable by the federal Food and Drug Administration, provides the national minimum standard for the proper handling of hazardous drugs to protect health care workers, patients, and the environment and will become effective (enforceable) December 1, 2019. In advance of the effective date of USP General Chapter 800, this amendment requires all pharmacies to ensure adequate protection of pharmacy personnel and patients from hazardous drugs and provides an official enforcement date for Iowa pharmacies to implement the standards identified in USP General Chapter 800.


Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on August 29, 2018, as ARC 3978C. The Board received two comments requesting clarification on the expected enforcement date in Iowa for standards identified in USP General Chapter 800. The amendment has been changed to instead provide a date upon which the Board intends to enforce the standards of USP Chapter 800, which is set for December 1, 2019 or later if so delayed by USP.


This rule making was adopted by the Board on ______, 2018. Fiscal Impact

It cannot be determined what, if any, fiscal impact this rule making will have to the state of Iowa. Of the few pharmacies funded by the state of Iowa, it is unknown to what degree hazardous drugs are in use and what safety methods have already been implemented.

Jobs Impact



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Effective Date

This rule making will become effective on ________, 2019. The following rule-making action is adopted:

Amend rule 657—8.5(155A) as follows:

657—8.5(155A) Environment and equipment requirements. There shall be adequate space, equipment, and supplies for the professional and administrative functions of the pharmacy pursuant to rule 657—8.3(155A). Space and equipment shall be available in an amount and type to provide secure, environmentally controlled storage of drugs shall be available. 8.5(1) to 8.5(10) No change. 8.5(11) Hazardous drugs. The pharmacy shall ensure pharmacy personnel and patients are adequately protected from unnecessary exposure to hazardous drugs. As of December 1, 2019, or the enforcement date identified by the United States Pharmacopeia (USP), whichever is later, the pharmacy shall be in compliance with USP General Chapter 800 for handling hazardous drugs.

ADDENDUM F

ADOPTION AND FILING

RESCINDING CHAPTER 17, “WHOLESALE DRUG LICENSES,” AND ADOPTING NEW CHAPTER 17, “WHOLESALE DISTRIBUTOR

LICENSES”

NOVEMBER 14, 2018

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Adopted and Filed

The Board of Pharmacy hereby rescinds Chapter 17, “Wholesale Drug Licenses,” and

adopts new Chapter 17, “Wholesale Distributor Licenses,” Iowa Administrative Code. Legal Authority for Rule Making

This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 155A.17.


This rule making implements, in whole or in part, Iowa Code sections 124.301 to 124.308, 126.3, 126.9 to 126.12, 155A.3 as amended by 2018 Iowa Acts, Senate File 2298, 155A.4, 155A.17 as amended by 2018 Iowa Acts, Senate File 2298, 155A.19, 155A.21, 155A.23 and 155A.40 and the Drug Supply Chain Security Act (DSCSA).

Purpose and Summary

In November 2013, Congress enacted the Drug Quality and Security Act, which included the Drug Supply Chain Security Act. DSCSA sets national minimum standards for entities engaged in the wholesale distribution of drugs in the United States. DSCSA also prohibits any state from enacting any law or rule more or less strict than DSCSA. The revised chapter establishes the minimum standards for wholesale distributor licenses and addresses the following topics: licensure and renewal processes; grounds for denial of licensure; required policies and procedures; requirements of facilities, security, and storage; reporting of discipline and convictions; and grounds for discipline.


Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on August 29, 2018, as ARC 3974C.

A public hearing was held on September 25, 2018, at 9:00 am at the offices of the Iowa Board of Pharmacy. The hearing was attended by representatives from the National Association of Boards of Pharmacy who provided verbal review of the association’s written comments.

The Board received a number of comments on this rule making. Five comments were received in opposition to the requirement that a wholesale distributor be VAWD-accredited. The reasons for the opposition included concern of the expense of attaining VAWD accreditation and the belief that the standard was inconsistent with federal law. The Board considered these comments and declined the requests to remove the requirement. Of the wholesale distributors which are currently licensed in Iowa, over 360 currently hold VAWD accreditation with an additional 35 in the process of obtaining accreditation. Less than 60 current Iowa-licensed wholesale distributors are not VAWD-accredited. Iowa would join three other states which also

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require this accreditation as a condition for licensure. Further, the Board agrees with the comments that the federal law intends to establish national minimum standards for wholesale distributors. Where the Board disagrees is with the assertion that the federal law on its own has established those standards. DSCSA directs FDA to publish regulations to implement the federal law and establish licensing standards. Those regulations were to have been published by November 1, 2015. To date, regulations have not been published. Further, the process of publication and public comment, not unlike Iowa’s rulemaking process, will take many months. The regulations then will not be effective until two years after the date of final publication in the federal register. Therefore, the minimum standards could be at least another three years away. Until those regulations are known, Iowa must ensure the legitimacy of the drug supply chain for products entering this state and the Board believes such accreditation will provide that assurance. The Board fully recognizes that, if the final FDA regulations do not allow or require such accreditation, the Board’s rule would be superseded as of the enforcement date of the federal regulation. Indeed, upon final publication, the Board will have two years to amend its rules to conform to the regulations.

Comments received also suggested revisions to the proposed rules relating to storage, records, purpose and scope, license application, license renewal, license denial, policies and procedures, and disciplinary action. The comment suggesting the addition of a new rule identifying all record keeping requirements was declined due to the rule which requires compliance with all federal laws and regulations, which includes all record keeping requirements. The comment proposing a revision to the purpose and scope relating to the federal preemption was declined as the language proposed is sufficient. Comments requesting changes to the background check, surety bond, and grace period subrules in licensure application and renewal; license denial subrules; and disciplinary action subrules were declined.

The comment suggesting a revision of the storage rule to provide more clarity was accepted. The comment seeking additional clarification on what “adequate experience” means was accepted and the subrule was amended to identify adequate experience to mean at least three years working in the business of prescription drug distribution. The comment requesting to remove the policy and procedure relating to drug stock distribution was accepted the requirement was removed. The comment requesting the removal of the FDA warning letter being conclusive evidence of a violation was accepted and the portion was removed.


This rule making was adopted by the Board on ___________, 2018. Fiscal Impact


After analysis and review of this rule making, no impact on jobs has been found. Waivers

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Effective Date

This rule making will become effective on _________, 2019. The following rule-making action is adopted:

Rescind 657—Chapter 17 and adopt the following new chapter in lieu thereof:

CHAPTER 17 WHOLESALE DISTRIBUTOR LICENSES

657—17.1(155A) Purpose and scope. This chapter establishes the licensing requirements and standards applicable to a wholesale distributor of human prescription drugs as defined by Iowa Code section 155A.3(49) as amended by 2018 Iowa Acts, Senate File 2298, and the Drug Supply Chain Security Act. In the event the requirements in this chapter directly conflict with any federal law or regulation, the federal law or regulation shall supersede the requirements in this chapter.

657—17.2(155A) Definitions. In addition to the definitions found in Iowa Code section 155A.3 as amended by 2018 Iowa Acts, Senate File 2298, which are adopted for the purposes of this chapter, the following definitions shall apply:

“Drug Supply Chain Security Act” or “DSCSA” means the law enacted by Congress in November 2013 which establishes the minimum standards for ensuring a legitimate drug supply chain.

“Facility manager” means the individual responsible for managing the daily operations of the wholesale distribution facility.

“FDA” means the United States Food and Drug Administration. “Returns processor” means a person who owns or operates an establishment that dispositions

or otherwise processes saleable or nonsaleable product received from a purchaser, manufacturer, or seller who purchased or received such product at wholesale, such that the product may be processed for credit to the purchaser, manufacturer, or seller, or disposed of for no further distribution.

“Wholesale distribution” means the distribution of a drug to a person other than a consumer or patient, or the receipt of a drug by a person other than a consumer or patient, but does not

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include transactions identified in Iowa Code section 155A.3(48) as amended by 2018 Iowa Acts, Senate File 2298, and DSCSA.

“Wholesale distributor” means a person, other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or a repackager, engaged in the wholesale distribution of a prescription drug.

657—17.3(155A) Wholesale distributor license. Every wholesale distributor that engages in wholesale distribution into, out of, or within this state must be licensed by the board before engaging in wholesale distribution. Where operations are conducted at more than one location by a single wholesale distributor, each such location shall be separately licensed. The applicant shall submit a completed application with a nonrefundable application fee of $750. A wholesale distributor that engages in wholesale distribution of controlled substances into, out of, or within this state shall also obtain a controlled substances Act registration pursuant to 657—Chapter 10. 17.3(1) Application. The applicant shall complete an application which requires demographic information about the wholesale distributor, ownership information, information about the wholesale distributor’s registered agent located in Iowa, information about the wholesale distributor’s licensure with other state and federal regulatory authorities, criminal and disciplinary history information, information regarding the facility manager, a detailed description of the services to be provided in this state, and other necessary information as determined by the board. An application for a wholesale distributor license, including an application for registration pursuant to 657—Chapter 10, if applicable, will become null and void if the applicant fails to complete the licensure process, including opening for business, within six months of receipt by the board of the required application(s). The following shall also be submitted by the applicant for the application to be considered complete: a. Criminal history record check. Upon receipt of a licensure application, the board shall provide a fingerprint packet to the applicant’s facility manager, who shall submit the completed fingerprint packet and a signed waiver form to facilitate a national criminal history background check of the facility manager. The cost of the evaluation of the fingerprint packet and the Iowa division of criminal investigation and the United States Federal Bureau of Investigation criminal history background checks will be assessed to the applicant. b. Surety bond or equivalent security. The applicant shall file with the board a $100,000 surety bond or evidence that the wholesale distributor possesses the required bond in another state where the wholesale distribution facility does business. If a wholesale distributor’s annual gross receipts from the previous tax year were $10 million or less, the wholesale distributor need only file a $25,000 surety bond. In lieu of a surety bond, the applicant may submit an irrevocable standby letter of credit in the amount of $100,000 or $25,000 as applicable. A government-owned wholesale distributor is exempt from the surety bond requirement. c. Evidence of current verified-accredited wholesale distributors (VAWD) accreditation by the National Association of Boards of Pharmacy. This requirement does not apply to new applicants located in Iowa which must undergo an opening inspection by a board compliance officer or agent of the board prior to issuance of an initial license. Wholesale distributors located

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in Iowa shall provide evidence of VAWD accreditation on or before license renewal. d. Attestation by facility manager. The applicant shall submit attestation that the facility manager has been employed full-time for at least three years in a position related to prescription drug distribution; is actively involved in the daily operation of the wholesale distribution facility; maintains a functional understanding of federal and state laws, rules, and regulations pertaining to wholesale drug distribution; and has no felony convictions or convictions related to prescription drug distribution, including distribution of controlled substances. 17.3(2) License renewal. A wholesale drug license shall be renewed before January 1 of each year and may be renewed as early as November 1 prior to expiration. The wholesale distributor shall submit a completed application and nonrefundable application fee as required in this rule. a. Delinquent license grace period. If a wholesale drug license has not been renewed or canceled prior to expiration, the license becomes delinquent on January 1. A wholesale distributor that submits a completed license renewal application, nonrefundable application fee, and nonrefundable late penalty fee of $750 postmarked or delivered to the board by January 31 shall not be subject to disciplinary action for continuing to provide services in this state in the month of January. b. Delinquent license reactivation beyond grace period. If a wholesale drug license has not been renewed prior to the expiration of the one-month grace period identified in paragraph 17.3(2)“a,” the wholesale distributor may not operate or do business in Iowa. A wholesale distributor that continues to do business in Iowa without a current license may be subject to disciplinary sanctions pursuant to the provisions of 657—subrule 36.6(22). A wholesale distributor without a current license may apply for reactivation by submitting a license application for reactivation and a nonrefundable $2,000 reactivation fee. As part of the reactivation application, the wholesale distributor shall disclose the services, if any, that were provided in this state while the license was delinquent. 17.3(3) License changes. When a licensed wholesale distributor changes its name, ownership, facility manager, or location, a wholesale drug license application with a nonrefundable application fee as provided in subrule 17.3(1) shall be submitted to the board. A change of ownership occurs when the owner listed on the wholesale distributor’s most recent application changes or when there is a change affecting the majority ownership interest of the owner listed on the wholesale distributor’s most recent application. A change of wholesale distributor location within Iowa, if the new location was not a licensed wholesale distributor immediately prior to the relocation, shall require an on-site inspection of the new location as provided in paragraph 17.3(1)“c.” a. Locations in Iowa. Applications for license changes shall be submitted to the board as far in advance as possible prior to the anticipated change. b. Locations outside of Iowa. Applications for license changes shall be submitted to the board within ten days of the wholesale distributor’s receipt of an updated license from the home state regulatory authority. c. License change application submission. Applications for license changes shall be timely

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submitted pursuant to this subrule. A licensed wholesale distributor that has timely submitted a license change application and fee may continue to service Iowa customers while the license change is pending final approval. An applicant that has submitted an application for license changes after the required date of submission pursuant to this subrule but within 30 days of the required date of submission shall be assessed a nonrefundable late penalty fee of $750 in addition to the license fee. An applicant that has submitted an application for license changes 31 days or later following the required date of submission pursuant to this subrule shall be assessed a nonrefundable reactivation fee of $2,000. 17.3(4) License cancellation. A licensee intending to discontinue wholesale distribution into, out of, or within this state shall notify the board in writing of its intent as far in advance as possible of the discontinuation of services and shall request that the license be administratively canceled. Such notification shall include the name and license number of the wholesale distributor, the anticipated date of discontinuation of service, and the identification of the wholesale distributor to which drugs and records will be transferred. To the extent possible to avoid unnecessary delays in obtaining product for patients, a wholesale distributor that intends to discontinue services in this state should provide advance notice to its customers of the date that the wholesale distributor intends to cease distribution in this state.

657—17.4(155A) Grounds for denial. The board may deny a wholesale distributor license application, or refuse to renew a wholesale distributor license, for any of the following: 1. Any criminal convictions of the applicant or facility manager related to wholesale distribution; 2. Any felony convictions of the applicant; 3. Insufficient experience in the wholesale distribution business, including a lack of knowledge regarding the requirements of applicable federal and state laws or regulations; 4. The furnishing of false or fraudulent material; 5. Suspension, revocation, or other disciplinary action taken by the licensing authority of another state or federal agency against any license or registration currently or previously held by the applicant; 6. Noncompliance with licensing requirements under previously granted licenses, if any; 7. Noncompliance with the requirements to maintain or make available to the board, its agents, or to federal, state, or local law enforcement officials those records required to be maintained by wholesale distributors; 8. Conducting transactions with a person that is not properly licensed or registered; and 9. Any other factors or qualifications the board considers relevant to and consistent with public health and safety.

657—17.5 and 17.6 Reserved.

657—17.7(124,155A) Compliance with federal and state laws. A wholesale distributor is responsible for complying with all applicable federal and state laws, including those not

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specifically identified in this chapter. 17.7(1) A licensed wholesale distributor shall meet the requirements set forth in the Drug Supply Chain Security Act, including but not limited to: a. 21 U.S.C. §360eee-1, relating to product tracing, product identifiers, authorized trading partners, suspect products, and illegitimate products; b. 21 U.S.C. §360eee-2, relating to national standards for drug wholesale distributors; and c. Any regulations promulgated thereunder. 17.7(2) A licensed wholesale distributor shall permit agents of the board to enter and inspect the facility for compliance with federal and state laws. A licensed wholesale distributor shall cooperate with other regulatory or law enforcement officials with jurisdiction over the facility.

657—17.8(124,155A) Written policies and procedures. Wholesale distributors shall establish, maintain, and adhere to written policies and procedures that are in compliance with federal law for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts and for correcting all errors and inaccuracies in inventories. Wholesale distributors shall also include in their written policies and procedures the following: 17.8(1) Recalls and market withdrawals. A procedure to be followed for handling recalls and withdrawals of prescription drugs. a. The procedure shall be adequate to deal with recalls and withdrawals due to: (1) Any action initiated at the request of the Food and Drug Administration or other federal, state, or local law enforcement agency or other government agency, including the board; (2) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or (3) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design. b. The requirement of this subrule shall not apply to a returns processor. 17.8(2) Emergency and disaster plan. A procedure to ensure that wholesale distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency. 17.8(3) Outdated drugs. A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. The requirement of this subrule shall not apply to a returns processor. 17.8(4) Security and storage. A procedure to ensure adequate security in accordance with rule 657—17.10(124,155A) and proper storage conditions in accordance with rule 657—17.11(155A). The requirement for proper storage conditions shall not apply to a returns processor. 17.8(5) Drugs supplied to salesperson/representative. If supplying drugs to wholesale distributor salespersons, a procedure directing that the security, storage, and record-keeping

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requirements contained in these rules shall be maintained by those salespersons. 17.8(6) Personnel. A procedure to ensure the wholesale distributor employs personnel with the education and experience appropriate to the responsibilities of the position held by the individual. Licensed wholesale distributors shall establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

657—17.9(155A) Facilities. All wholesale distribution facilities shall: 1. Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations; 2. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions; 3. Except for returns processors, have a quarantine area for storage of outdated, damaged, unsafe, deteriorated, misbranded, or adulterated prescription drugs; for drugs that are in immediate or sealed outer or sealed secondary containers that have been opened; for drugs that have been identified as being defective or are believed to be defective; and for drugs that do not meet the FDA-approved criteria for the product; 4. Be maintained in a clean and orderly condition; 5. Be free from infestation by insects, rodents, birds, or vermin of any kind.

657—17.10(124,155A) Security. 17.10(1) Secure from unauthorized entry. All wholesale distribution facilities shall be secure from unauthorized entry. a. Access from outside the premises shall be kept to a minimum and be well controlled. b. The outside perimeter of the premises shall be well lighted. c. Entry into areas where prescription drugs are held shall be limited to authorized personnel. 17.10(2) Alarm. All wholesale distribution facilities shall be equipped with an alarm system to deter entry after hours. 17.10(3) Security system. All wholesale distribution facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

657—17.11(155A) Storage and handling. All prescription drugs shall be stored and shipped at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs or with requirements in the current edition of the United States Pharmacopeia. Manual, electromechanical, or electronic temperature and humidity monitoring and recording equipment, devices, or logs shall be utilized to document proper storage of prescription drugs to prevent and detect excursions. Shipment of prescription drugs requiring refrigeration shall maintain temperature requirements as in accordance with the manufacturer

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requirements or as described in the current edition of the United States Pharmacopeia. All excursions shall be evaluated to determine any adverse impact on the integrity of the drug. The requirements of this rule do not apply to non-saleable returns handled by returns processors.

657—17.12 to 17.16 Reserved.

657—17.17(155A) Reporting discipline and criminal convictions. No later than 30 days after the final action, a wholesale distributor shall provide to the board written notice, including an unredacted copy of the action or order, of any disciplinary or enforcement action imposed by any licensing or regulatory authority on any license or registration held by the wholesale distributor. Discipline may include, but is not limited to, fine or civil penalty, citation or reprimand, probationary period, suspension, revocation, and voluntary surrender. No later than 30 days after conviction, a wholesale distributor shall provide to the board written notice, including an unredacted copy of the judgment of conviction or sentence, of any criminal conviction of the wholesale distributor, any owner of the wholesale distributor, or facility manager, if the conviction is related to prescription drug distribution. The term “criminal conviction” includes instances when the judgment of conviction or sentence is deferred.

657—17.18(155A) Discipline. Pursuant to 657—Chapter 36, the board may fine, suspend, revoke, or impose other disciplinary sanctions on a wholesale distributor license for any of the following: 1. Any violation of the federal Food, Drug, and Cosmetic Act or federal regulation promulgated under the Act. 2. Any conviction of a crime related to the distribution of prescription drugs committed by the wholesale distributor, its owners, or the facility manager. 3. Refusing access to the wholesale distribution facility or records to an agent of the board for the purpose of conducting an inspection or investigation. 4. Failure to maintain registration pursuant to 657—Chapter 10 when distributing controlled substances into, out of, or within this state. 5. Any act of unethical or unprofessional conduct by an employee of the wholesale distributor. 6. Any violation of Iowa Code chapter 124, 126, 155A, or 205, or rule of the board, including the disciplinary grounds set forth in 657—Chapter 36.

These rules are intended to implement Iowa Code sections 124.301 through 124.308, 126.3, 126.9 through 126.12, 155A.4, 155A.19, 155A.21, 155A.23, and 155A.40; Iowa Code sections 155A.3 and 155A.17 as amended by 2018 Iowa Acts, Senate File 2298; and the federal Drug Supply Chain Security Act.

ADDENDUM G

ADOPTION AND FILING

ADOPTING NEW CHAPTER 42, “LIMITED DISTRIBUTOR LICENSES”

NOVEMBER 14, 2018

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Adopted and Filed

The Board of Pharmacy hereby adopts new Chapter 42, “Limited Distributor Licenses,”

Iowa Administrative Code. Legal Authority for Rule Making

This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 155A.42.


This rule making implements, in whole or in part, Iowa Code sections 124.301 to 124.308, 126.3, 126.9 to 126.12, 126.22, 155A.4, 155A.13, 155A.21, and 155A.23 and sections 155A.3, 155A.17, and 155A.42 as amended by 2018 Iowa Acts, Senate File 2298.

Purpose and Summary

Pursuant to Iowa Code section 155A.42, the Board adopts this new chapter to establish the minimum standards for entities that are engaged in the distribution of prescription drugs and devices but that do not meet the definition of a wholesale distributor. The rules address licensure and renewal processes, grounds for licensure denial, required policies and procedures, facility and operation requirements, records requirements, reporting of discipline or convictions, and grounds for discipline.



A public hearing was held on September 25, 2018 at 9:00 a.m. at the offices of the Iowa Board of Pharmacy. The hearing was attended by representatives of the National Association of Boards of Pharmacy (NABP) who provided verbal review of the association’s written comments.

The Board received comments from three entities identifying this rule making. Comments from NABP were neutral on the rule making and concluded that the rules would not be inconsistent with federal law. One comment was in opposition to the licensure requirement for “intra-company distributions” and requested such distribution sites be exempt from licensure. Another commenter suggested changes or clarification to the proposed rules relating to licensure, the license renewal process, and disciplinary action. The Board declined the requested changes and suggestions.

No changes to the rule making have been made and the adopted chapter is identical to that published for Notice.


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This rule making was adopted by the Board on __________, 2018. Fiscal Impact






Effective Date

This rule making will become effective on __________, 2019. The following rule-making action is adopted:

Adopt the following new 657—Chapter 42:

CHAPTER 42 LIMITED DISTRIBUTOR LICENSES

657—42.1(155A) Purpose and scope. The purpose of this chapter is to establish the minimum standard of practice for limited drug and device distribution in the state of Iowa. This chapter applies to a person who is involved in the distribution of drugs and devices but who does not meet the definition of a wholesale distributor under federal or state law. In addition to the rules of the board, any distribution of prescription drugs and devices shall be in compliance with all applicable federal and state laws and regulations.

657—42.2(155A) Definitions. In addition to the definitions found in Iowa Code section 155A.3 as amended by 2018 Iowa Acts, Senate File 2298, which are adopted for the purposes of this chapter, the following definitions shall apply:

“Board” means the Iowa board of pharmacy. “Distribute” means the delivery or transfer of a prescription drug or device from one person

to another. “Facility manager” means the individual responsible for managing the daily operations of

the limited distributor facility. “Limited distributor” means a person operating or maintaining a location, regardless of the

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location, where prescription drugs or devices are manufactured, repackaged, distributed at wholesale, or distributed to a patient pursuant to a prescription drug order, who is not eligible for a wholesale distributor license or a pharmacy license. Included in the definition of “limited distributor” are the activities identified in subrule 42.3(1).

657—42.3(155A) Limited distributor license. Beginning January 1, 2019, no person other than a licensed wholesale distributor, licensed pharmacy, or practitioner shall engage in any of the activities found herein in this state without a limited distributor license. Where operations are conducted at more than one location by a single distributor, each location shall be separately licensed. The applicant shall submit a completed application along with a nonrefundable fee of $175. A limited distributor that engages in distribution of controlled substances into, out of, or within this state shall also obtain a controlled substances Act registration pursuant to 657—Chapter 10. 42.3(1) License required. A person engaged in the following activities shall obtain a limited distributor license prior to distribution in or into Iowa: a. Distribution of a medical gas or device at wholesale or to a patient pursuant to a prescription drug order. b. Wholesale distribution of a prescription animal drug. c. Wholesale distribution of a prescription drug, or brokering the distribution of a prescription drug at wholesale, by a manufacturer, a manufacturer’s co-licensed partner, or a repackager. d. Intracompany distribution of a prescription drug, including pharmacy chain distribution centers. e. Distribution at wholesale of a combination product as defined by the United States Food and Drug Administration, medical convenience kit, intravenous fluid or electrolyte, dialysis solution, radioactive drug, or irrigation or sterile water solution to be dispensed by prescription only. f. Distribution of a dialysis solution by the manufacturer or the manufacturer’s agent to a patient pursuant to a prescription drug order, provided that a licensed pharmacy processes the prescription drug order. 42.3(2) License optional. A person engaged in the following activities may, but is not required to, obtain a limited distributor license for distribution in or into Iowa: a. Distribution of nonprescription drugs or devices with or without a patient-specific prescription. b. Distribution of medical devices exclusively to a health care practitioner for use in the normal course of professional practice (“professional use”). c. Distribution of blood and blood products that are not subject to the federal Drug Supply Chain Security Act (DSCSA). 42.3(3) Application. The applicant shall complete an application which requires demographic information about the limited distributor, ownership information, information about the limited distributor’s registered agent located in Iowa, information about the limited distributor’s

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licensure with other state and federal regulatory authorities, criminal and disciplinary history information, information regarding the facility manager, and a detailed description of the services to be provided in this state. An application for a limited distributor license, including an application for registration pursuant to 657—Chapter 10, if applicable, will become null and void if the applicant fails to complete the licensure process, including opening for business, within six months of receipt by the board of the required application(s). The following shall also be submitted by the applicant for the application to be considered complete: a. Evidence of the mandatory physical inspection of the distribution facility pursuant to subrule 42.3(7). b. Attestation by facility manager. The applicant shall submit attestation that the facility manager has adequate experience in prescription drug and device distribution; is actively involved in the daily operation of the distribution facility; maintains a functional understanding of federal and state laws, rules, and regulations pertaining to drug and device distribution, as applicable; and has no felony convictions or convictions related to prescription drug and device distribution, including distribution of controlled substances. 42.3(4) License renewal. A limited distributor license shall be renewed before January 1 of each year and may be renewed as early as November 1 prior to expiration. The limited distributor shall submit a completed application and nonrefundable application fee as required in this rule. a. Delinquent license grace period. If a limited distributor license has not been renewed or canceled prior to expiration, the license becomes delinquent on January 1. A limited distributor that submits a completed license renewal application, nonrefundable application fee, and nonrefundable late penalty fee of $175 postmarked or delivered to the board by January 31 shall not be subject to disciplinary action for continuing to provide services in this state in the month of January. b. Delinquent license reactivation beyond grace period. If a limited distributor license has not been renewed prior to the expiration date of the one-month grace period identified in paragraph 42.3(4)“a,” the limited distributor may not operate or do business in Iowa, unless the activities conducted are those identified in subrule 42.3(2). A limited distributor that continues to do business in Iowa without a current license as required in subrule 42.3(1) may be subject to disciplinary sanctions pursuant to the provisions of 657—subrule 36.6(2). A limited distributor without a current license may apply for reactivation by submitting a license application for reactivation and a nonrefundable reactivation fee of $500. As part of the reactivation application, the limited distributor shall disclose the services, if any, that were provided in this state while the license was delinquent. 42.3(5) License changes. If a distributor has a change of name, ownership, or location, a limited distributor license application with a nonrefundable application fee as provided in subrule 42.3(3) shall be submitted to the board. A change of ownership occurs when the owner listed on the limited distributor’s most recent application changes or when there is a change affecting the majority ownership interest of the owner listed on the limited distributor’s most recent

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application. A change of limited distributor location within Iowa, if the new location was not a licensed limited distributor immediately prior to the relocation, shall require a self-inspection as provided in subrule 42.3(7). A limited distributor that has submitted a license change application may continue to service Iowa customers while its license change is pending final approval. a. For a distributor located in Iowa, a completed application shall be submitted to the board as far in advance as possible prior to the change of name, ownership, or location. b. For a distributor located outside of Iowa: (1) If the home state licenses or registers the facility, a completed application shall be submitted within ten days of receipt of an updated license or registration from the home state. (2) If the home state does not license or register the facility, a completed application shall be submitted as far in advance as possible prior to the change of name, ownership, or location. c. When a distributor changes its name or location, the distributor shall provide advance written notice of the change to each Iowa customer and patient. d. Applications for license changes shall be timely submitted pursuant to this subrule. A licensed limited distributor that has timely submitted a license change application and fee may continue to service Iowa customers while the license change is pending final approval. An applicant that has submitted an application for license changes after the required date of submission pursuant to this subrule but within 30 days of the required date of submission shall be assessed a nonrefundable late penalty fee of $175 in addition to the license fee. An applicant that has submitted an application for license changes 31 days or later following the required date of submission pursuant to this subrule shall be assessed a nonrefundable reactivation fee of $500. 42.3(6) License cancellation. If a limited distributor intends to discontinue service into, out of, or within this state, it shall: a. Notify the board as far in advance as possible of the limited distributor’s intent to discontinue services and shall request that the license be administratively canceled. The notification shall include the name, address, and Iowa license number of the pharmacy or distributor at which prescription, patient, and distribution records will be maintained. b. Ensure that prescription and patient records are transferred to another Iowa-licensed distributor or pharmacy. c. To the extent possible to avoid unnecessary delays in the availability of services to Iowa customers and patients, provide advance written notice to customers and patients of the date that the distributor intends to cease provision of services. 42.3(7) Inspection of limited distributor facility. Each limited distributor location seeking initial or renewal licensure shall, prior to issuance of a license certificate, complete and submit for evaluation a self-inspection packet provided by the board.


657—42.6(155A) Grounds for denial. The board may deny a limited distributor license application, or refuse to renew a license, for any of the following: 1. Any criminal convictions of the applicant related to the distribution of drugs or devices;

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2. Any felony convictions of the applicant; 3. Insufficient experience in the distribution of prescription drugs or devices, including a lack of knowledge regarding the requirements of applicable federal and state laws or regulations; 4. The furnishing of false or fraudulent material; 5. Suspension, revocation, or other disciplinary action taken by the licensing authority of another state or federal agency against any license or registration currently or previously held by the applicant; 6. Noncompliance with licensing requirements under previously granted licenses, if any; 7. Noncompliance with the requirements to maintain or make available to the board, its agents, or to federal, state, or local law enforcement officials those records required to be maintained; 8. Conducting transactions with a person that is not properly licensed, registered, or authorized; and 9. Any other factors or qualifications the board considers relevant to and consistent with public health and safety.

657—42.7(155A) Policies and procedures. 42.7(1) Distributors shall have for all aspects of the distributor’s operation policies and procedures that, at a minimum, address the rules in this chapter and any other applicable federal, state, and local laws, rules, and regulations. 42.7(2) The policies shall address, at a minimum: a. Security of the facility and of patient information; b. Storage of products, including proper storage conditions and handling of outdated, recalled, and returned products; c. Records, including the retention period for all required records; d. Security, storage and records for products in the possession of a distributor’s authorized representative; and e. Employment of personnel with education and experience appropriate to the responsibilities of the position held.


657—42.10(155A) Requirements. 42.10(1) Physical requirements. A distributor’s location shall: a. Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations; b. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions; c. Have a quarantine area for storage of outdated, damaged, unsafe, deteriorated, misbranded, or adulterated products and for any suspect products; d. Be maintained in a clean and orderly condition;

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e. Be free from infestation by insects, rodents, birds, or vermin of any kind. 42.10(2) Operation requirements. Distributors shall operate in compliance with all applicable federal, state, and local laws, rules, and regulations. a. Purchasing. Distributors shall purchase products from a legitimate source that is properly licensed in the state in which it is located and that is properly licensed in the distributor’s home state, if such licensure is required. Distributors shall exercise due diligence in determining the legitimacy of a product’s source and maintain documentation of the distributor’s verification of the legitimate source. b. Examination of materials. Distributors shall ensure, upon receipt and prior to distribution, that a product is suitable for distribution. c. Verification. Qualified personnel shall verify, prior to distribution, that the product matches the order for which the product is being distributed. d. Instructions for use. Qualified personnel shall provide to the patient or the patient’s caregiver adequate instructions for use when a product is distributed pursuant to a prescription order.

657—42.11 Reserved.

657—42.12(155A) Records. Distributors shall establish and maintain records of all transactions regarding the receipt and distribution or other disposition of products, including outdated, damaged, deteriorated, misbranded, or adulterated products. 42.12(1) Transaction records. Records for receipt and distribution transactions for all products shall include the following information: a. The source of the products, including the name and principal address of the seller or transferor and the address of the location from which the products were shipped; b. The identity and quantity of the products received or distributed; c. The date of receipt or distribution of the products; and d. The identity of the purchaser of the products, including the name and principal address of the purchaser or transferee and the address to which the products were shipped or distributed. 42.12(2) Prescription order records. Each prescription order that results in the distribution of a product shall be retained, in the original format received, and be available for inspection and copying by the board, its representative, or other authorized individual for at least two years from the date of last activity of the prescription order. a. Prescription orders shall contain all the required elements identified in Iowa Code section 155A.27. b. Prescription orders for noncontrolled prescription drugs shall be valid for no longer than 18 months following the date issued or 13 fills, whichever is less. c. A one-month supply of a medical gas, such as oxygen, shall be considered to be a single refill. Such prescription must be reissued at least every 13 months. d. Prescription orders for controlled substances shall be valid for no longer than six months following the date issued or six fills, whichever is less.

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42.12(3) Records maintained. All records generated pursuant to the distributor’s policies and procedures, this chapter, and all federal, state, and local rules, laws and regulations shall be maintained, readily retrievable, and available for inspection and copying by the board, its representative, or other authorized individual for at least two years from the date of the record. 42.12(4) Confidentiality of patient information. Any patient information in the possession of a distributor shall be maintained in compliance with the patient confidentiality and security requirements of 657—Chapter 8, 657—Chapter 21, and federal law.


657—42.14(155A) Reporting discipline and criminal convictions. No later than 30 days after the final action, a limited distributor shall provide to the board written notice, including an unredacted copy of the action or order, of any disciplinary or enforcement action imposed by any licensing or regulatory authority on any license or registration held by the distributor. Discipline may include, but is not limited to, fine or civil penalty, citation or reprimand, probationary period, suspension, revocation, and voluntary surrender. No later than 30 days after the conviction, a limited distributor shall provide to the board written notice, including an unredacted copy of the judgment of conviction or sentence, of any criminal conviction of the distributor, any owner of the distributor, or any individual responsible for managing the daily operations of the distribution facility, if the conviction is related to prescription drug or device distribution. The term “criminal conviction” includes instances when the judgment of conviction or the sentence is deferred.

657—42.15(155A) Discipline. Pursuant to 657—Chapter 36, the board may fine, suspend, revoke, or impose other disciplinary sanctions on a limited distributor license for any of the following: 1. Any violation of the federal Food, Drug, and Cosmetic Act or federal regulation promulgated under the Act. A warning letter issued by the United States Food and Drug Administration shall be conclusive evidence of a violation. 2. Any conviction of a crime related to the distribution of prescription drugs or devices committed by the distributor, its owners, or the facility manager. 3. Refusing access to the distribution facility or records to an agent of the board for the purpose of conducting an inspection or investigation. 4. Failure to maintain registration pursuant to 657—Chapter 10 when distributing controlled substances into, out of, or within this state. 5. Any act of unethical or unprofessional conduct by an employee of the distributor. 6. Any violation of Iowa Code chapter 124, 126, 155A, or 205, or rule of the board, including the disciplinary grounds set forth in 657—Chapter 36.

These rules are intended to implement Iowa Code sections 124.301 through 124.308, 126.3, 126.9 through 126.12, 126.22, 155A.4, 155A.13, 155A.21, and 155A.23 and sections 155A.3, 155A.17, and 155A.42 as amended by 2018 Iowa Acts, Senate File 2298.

ADDENDUM H

ADOPTION AND FILING

ADOPTING NEW CHAPTER 43, “THIRD-PARTY LOGISTICS PROVIDER LICENSES”

NOVEMBER 14, 2018

1


Adopted and Filed

The Board of Pharmacy hereby adopts new Chapter 43, “Third-Party Logistics Provider

Licenses,” Iowa Administrative Code. Legal Authority for Rule Making

This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 2018 Iowa Acts, Senate File 2298.


This rule making implements, in whole or in part, Iowa Code chapter 124B and sections 124.301 to 124.308, 126.3, 126.9 to 126.12, 155A.3, 155A.4 and 155A.40; 2018 Iowa Acts, Senate File 2298; and the Drug Supply Chain Security Act.

Purpose and Summary

Pursuant to 2018 Iowa Acts, Senate File 2298 [Iowa Code section 155A.17A], the Board adopts this new chapter to establish the minimum standards for entities engaged in third-party logistics of prescription drugs and devices as established in the Drug Supply Chain Security Act (DSCSA), enacted by Congress in November 2013. The rules address licensure and renewal processes, required policies and procedures, required reporting of discipline and convictions, and grounds for disciplinary action.



A public hearing was held on September 25, 2018, at 9:00 a.m. at the offices of the Iowa Board of Pharmacy. The hearing was attended by representatives of the National Association of Boards of Pharmacy who provided verbal review of the association’s written comments.

The Board received comments from four entities relating to this rule making. One comment proposed a revision to the purpose and scope language relating to federal preemption. One comment recommended a new rule to identify the federal record keeping requirements. The Board declined these recommended changes.

One comment requested a change to the language relating to an applicant providing evidence of FDA licensure. Another comment identified in incorrect reference to a DSCSA section number. These comments were accepted by the Board and the rules were amended accordingly.


This rule making was adopted by the Board on ______________, 2018.

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Fiscal Impact


After analysis and review of this rule making, no impact on jobs has been found.

Waivers




Effective Date

This rule making will become effective on ________, 2019. The following rule-making action is adopted:

Adopt the following new 657—Chapter 43:

CHAPTER 43 THIRD-PARTY LOGISTICS PROVIDER LICENSES

657—43.1(87GA,SF2298) Purpose and scope. The purpose of this chapter is to establish the minimum standards required of third-party logistics providers as defined in 2018 Iowa Acts, Senate File 2298, section 6, in this state pursuant to national standards as established by federal law. This chapter applies to logistics providers operating in or into this state. A 3PL does not include an entity that solely engages in shipping activities. Applicable activities of a 3PL include, but are not limited to, picking, packing, and shipping; inventory management; and warehousing or distribution management. In the event the requirements of this chapter directly conflict with any federal law or regulation, the federal law or regulation shall supersede the requirements in this chapter.

657—43.2(87GA,SF2298) Definitions. For the purposes of this chapter, the definitions found in Iowa Code section 155A.3 as amended by 2018 Iowa Acts, Senate File 2298, and the following definitions apply.

“Board” means the Iowa board of pharmacy. “Facility manager” means the individual who is responsible for the daily operation of a

third-party logistics licensed location.

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“FDA” means the United States Food and Drug Administration. “Home state” means the state in which a third-party logistics provider is located. “Third-party logistics provider” or “3PL” means an entity that provides or coordinates

warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product nor have responsibility to direct the sale or other disposition of the product.

657—43.3(87GA,SF2298) 3PL license. Beginning April 1, 2019, every 3PL as defined in rule 657—43.2(87GA,SF2298), wherever located, that provides or coordinates warehousing or other logistics services of products into, out of, or within this state must be licensed by the board in accordance with the laws and rules of Iowa before engaging in such logistics operations. Where activities are conducted at more than one location by a single 3PL, each location shall be separately licensed. The applicant shall submit a completed application with a nonrefundable application fee of $750. A 3PL that handles controlled substances shall also obtain a controlled substances Act registration pursuant to 657—Chapter 10. 43.3(1) Application. The applicant shall complete an application which requires demographic information about the 3PL, ownership information, information about the 3PL’s registered agent located in Iowa, information about the 3PL’s licensure or registration with other state and federal regulatory authorities, criminal and disciplinary history information, and a description of the scope of services to be provided in Iowa. If the applicant is not located in Iowa, the applicant shall submit evidence that the applicant has a valid license or registration in the home state or provide evidence that the home state does not require licensure. The applicant shall provide evidence of current verified-accredited wholesale distributors (VAWD) accreditation by the National Association of Boards of Pharmacy. This requirement does not apply to new applicants located in Iowa which must undergo an opening inspection by a board compliance officer or agent of the board prior to issuance of an initial license pursuant to subrule 43.3(3). 3PL distributors located in Iowa shall provide evidence of VAWD accreditation on or before license renewal. An application for a 3PL license, including an application for registration pursuant to 657—Chapter 10, if applicable, will become null and void if the applicant fails to complete the licensure process, including opening for business, within six months of receipt by the board of the required application(s). 43.3(2) Facility manager. The applicant shall attest that the facility manager has adequate experience in providing or coordinating warehousing or other logistics services of products; is actively involved in the daily operation of the facility; maintains a functional understanding of federal and state laws, rules, and regulations pertaining to drug and device distribution; and has no felony conviction or convictions related to prescription drug or device distribution, including distribution of controlled substances. Upon receipt of a licensure application, the board shall provide a fingerprint packet to the applicant’s facility manager, who shall submit the completed fingerprint packet and a signed waiver form to facilitate a national criminal history background check of the facility manager. The cost of the evaluation of the fingerprint packet and the Iowa division of criminal investigation and the United States Federal Bureau of Investigation criminal

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history background checks will be assessed to the applicant. 43.3(3) Inspection of new 3PL facility. Each new 3PL location seeking licensure shall be inspected prior to issuance of a license. a. Iowa location. If the applicant is located within Iowa, an inspection shall be conducted by the board or its authorized agent prior to issuance of the license and periodically thereafter. b. Nonresident location. If the applicant is located outside of Iowa, an inspection shall be conducted by the applicant’s home state regulatory authority or another board-approved inspecting authority and a report of such inspection shall be submitted with the application. The application shall also include evidence of corrective action taken to satisfy any deficiencies identified in the inspection report and compliance with all legal directives of the inspecting authority, if applicable. With each license renewal and license reactivation for a 3PL outside of Iowa, the application shall include a copy of the most recent inspection report issued as a result of an inspection conducted by the home state regulatory authority or other board-approved inspecting authority. 43.3(4) License renewal. The 3PL license shall be renewed by April 1 each year. The 3PL shall submit the completed license application and nonrefundable application fee of $750. A 3PL may renew its license beginning February 1 prior to license renewal. An initial 3PL license issued between February 1 and March 31 shall not require renewal until the following calendar year. a. Delinquent license grace period. If a 3PL license has not been renewed or canceled prior to expiration, but the 3PL is in the process of renewing the license, the license becomes delinquent on April 1. A 3PL that submits a completed license renewal application, nonrefundable application fee, and nonrefundable late penalty fee of $750 postmarked or delivered to the board by April 30 shall not be subject to disciplinary action for continuing to provide services to Iowa customers in the month of April. b. Delinquent license reactivation beyond grace period. If a 3PL license has not been renewed prior to the expiration of the one-month grace period identified in paragraph 43.3(4)“a,” the 3PL may not continue to provide services to Iowa customers. A 3PL that continues to provide services to Iowa customers without a current license may be subject to disciplinary sanctions. A 3PL without a current license may apply for reactivation by submitting a license application for reactivation and a nonrefundable reactivation fee of $2,000. As part of the reactivation application, the 3PL shall disclose the services, if any, that were provided to Iowa customers while the license was delinquent. 43.3(5) License changes. When a licensed 3PL changes its name, ownership, location, or facility manager, a completed 3PL license application with nonrefundable fee of $750 shall be submitted to the board. A change of ownership occurs when the owner listed on the 3PL’s most recent application changes or when there is a change affecting the majority ownership interest of the owner listed on the 3PL’s most recent application. A change of 3PL location within Iowa, if the new location was not a licensed 3PL immediately prior to the relocation, shall require an on-site inspection of the new location as provided in subrule 43.3(3). A 3PL that has submitted a

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license change application may continue to service Iowa customers while its license change is pending final approval. a. Locations in Iowa. An application for license change shall be submitted to the board as far in advance as possible prior to the anticipated change. b. Locations outside of Iowa. An application for license change shall be submitted to the board within ten days of the 3PL’s receipt of an updated license or registration from the home state regulatory authority or the FDA, as applicable. c. License change application submission. Applications for license changes shall be timely submitted pursuant to this subrule. A licensed 3PL that has timely submitted a license change application and fee may continue to service Iowa customers while the license change is pending final approval. An applicant that has submitted an application for license changes after the required date of submission pursuant to this subrule but within 30 days of the required date of submission shall be assessed a nonrefundable late penalty fee of $750 in addition to the license fee. An applicant that has submitted an application for license changes 31 days or later following the required date of submission pursuant to this subrule shall be assessed a nonrefundable reactivation fee of $2,000. 43.3(6) License cancellation. If a 3PL intends to discontinue service into, out of, or within this state, the licensee shall notify the board and shall request that the license be administratively canceled.


657—43.5(87GA,SF2298) Compliance with federal and state laws. A 3PL is responsible for complying with all applicable federal and state laws, including those not specifically identified in this chapter. 1. A licensed 3PL shall meet the requirements set forth in the Drug Supply Chain Security Act, 21 U.S.C. §360eee-3, relating to third-party logistics and regulations promulgated thereunder. 2. A licensed 3PL shall permit agents of the board to enter and inspect the facility for compliance with federal and state laws. A licensed 3PL shall cooperate with other regulatory or law enforcement officials with jurisdiction over the facility.

657—43.6(87GA,SF2298) Policies and procedures. A licensed 3PL shall establish, maintain, and adhere to written policies and procedures that are in compliance with standards established pursuant to federal and Iowa law and which address, at a minimum, the following: 1. Storage practices; 2. Maintaining adequate security; 3. Receipt, inventory, shipment, and distribution of product; 4. Theft or loss; 5. Inventory errors and inaccuracies; 6. Manufacturer recalls and withdrawals;

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7. Emergency and disaster plan; 8. Records, including the retention period for all required records; 9. Drug diversion detection and prevention; and 10. Outdated, adulterated, or suspect products.


657—43.9(87GA,SF2298) Reporting discipline and criminal conviction. No later than 30 days after the final action, a 3PL shall provide to the board written notice, including an unredacted copy of the action or order, of any disciplinary sanction imposed on any license or registration held by the 3PL or its owner or owners. Discipline may include, but is not limited to, fine or civil penalty, citation or reprimand, probationary period, suspension, revocation, and voluntary surrender. No later than 30 days after the conviction, a 3PL shall provide to the board written notice, including an unredacted copy of the judgment of conviction or sentence, of any criminal convictions related to product distribution, including convictions of any of its owners, or its facility manager. The term “criminal conviction” includes instances when the judgment of conviction or the sentence is deferred.

657—43.10(87GA,SF2298) Discipline. Pursuant to 657—Chapter 36, the board may fine, suspend, revoke, or impose other disciplinary sanctions on a 3PL license for any of the following: 1. Any violation of the federal Food, Drug, and Cosmetic Act or federal regulation promulgated under the Act related to third-party logistics and drug or device distribution. 2. Any conviction of a crime related to the distribution of prescription drugs or devices committed by the 3PL, its owners, or the facility manager. 3. Refusing access to the 3PL facility or records to an agent of the board or other authorized regulatory authority for the purpose of conducting an inspection or investigation. 4. Failure to maintain registration pursuant to 657—Chapter 10 when distributing controlled substances into, out of, or within this state. 5. Any act of unethical or unprofessional conduct by an employee of the 3PL. 6. Any violation of Iowa Code chapter 124, 126, 155A, or 205, or rule of the board, including the disciplinary grounds set forth in 657—Chapter 36.

These rules are intended to implement Iowa Code sections 124.301 through 124.308, 124B, 126.3, 126.9 through 126.12, 155A.3, 155A.4, and 155A.40; 2018 Iowa Acts, Senate File 2298; and the federal Drug Supply Chain Security Act.

ADDENDUM I

NOTICE OF INTENDED ACTION

TO RESCIND CHAPTER 37, “IOWA PRESCRIPTION MONITORING PROGRAM,” AND ADOPT NEW CHAPTER 37, “IOWA

PRESCRIPTION MONITORING PROGRAM”

NOVEMBER 14, 2018

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PHARMACY BOARD [657] Notice of Intended Action

The Board of Pharmacy hereby proposes to rescind Chapter 37, “Iowa Prescription Monitoring Program,” and adopt new Chapter 37, “Iowa Prescription Monitoring Program,” Iowa Administrative Code.

Legal Authority for Rule Making This rule making is proposed under the authority provided in Iowa Code section 124.554.

State or Federal Law Implemented This rule making implements, in whole or in part, Iowa Code sections 124.550 to

124.554, as amended by 2018 Iowa Acts, House File 2377; 124.551A as created by 2018 Iowa Acts, House File 2377; 124.555; and 124.556 to 124.558, as amended by 2018 Iowa Acts, House File 2377.

Purpose and Summary During the 2018 legislative session, changes were made the Iowa Code which affect the

Iowa Prescription Monitoring Program (PMP), including a requirement that prescribing practitioners register with the PMP simultaneous to CSA registration, authorization for the Board to assess up to a 25% surcharge on CSA registrations to be deposited into the PMP fund, a requirement that the dispensing of controlled substances by prescribers be reported to the PMP, and a requirement that administration of an opioid antagonist by a first responder be reported to the PMP.

The Board and the PMP Advisory Council also took this opportunity to conduct an overall review of the chapter as required by Iowa Code section 17A.7(2) and made changes to provide clarity where needed, and reorganize and simplify where appropriate. To further the goal of program utilization, the Board and the PMP Advisory Council propose that pharmacists who are involved in direct patient care shall also be required to register with the PMP simultaneous to licensure or renewal. The proposed rules also remove the specific number of authorized delegates to allow practitioners the ability to designate delegates according to their individual practice settings.

Fiscal Impact At this time, this rule making has no fiscal impact to the state of Iowa. PMP upgrades and

enhancements to implement the required reporting functions are funded at this time through grants obtained by the Board and the Iowa Department of Public Health. Due to these funding sources, the Board does not have immediate plans to implement the surcharge on CSA registrations.

Jobs Impact After analysis and review of this rule making, no impact on jobs can be determined.

Waivers Any person who believes that the application of the discretionary provisions of this rule

making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34.

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Public Comment Any interested person may submit comments concerning this proposed rule making.

Written comments in response to this rule making must be received by the Board no later than 4:30 p.m. on _________, 2018. Comments should be directed to:

Sue Mears, RPh Iowa Board of Pharmacy 400 S.W. 8th Street, Suite E Des Moines, Iowa 50309 Email: [email protected]

Public Hearing No public hearing is scheduled at this time. As provided in Iowa Code section

17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members.

Review by Administrative Rules Review Committee The Administrative Rules Review Committee, a bipartisan legislative committee which

oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

The following rule-making action is proposed: Rescind 657—Chapter 37 and adopt the following new chapter in lieu thereof:

CHAPTER 37 IOWA PRESCRIPTION MONITORING PROGRAM

657—37.1(124) Purpose and scope. These rules establish a prescription monitoring program (PMP) that compiles a central database of reportable prescriptions dispensed to patients in Iowa. An authorized health care practitioner shall access PMP information when mandated by the practitioner’s licensing authority regarding the practitioner’s patient to assist in determining appropriate treatment options and to improve the quality of patient care. The PMP is intended to provide a practitioner with a resource for information regarding a patient’s use of controlled substances and as a tool to assess a prescriber’s prescribing practices. This database will assist the practitioner in identifying any potential diversion, misuse, or abuse of controlled substances without impeding the appropriate medical use of controlled substances. 657—37.2(124) Definitions. For the purposes of this chapter, the following definitions shall apply. “Board” means the Iowa board of pharmacy. “Controlled substance” means a drug in Schedules II through IV set forth in Iowa Code chapter 124, division II.

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“Council” means the PMP advisory council established pursuant to Iowa Code section 124.555 to provide oversight and to co-manage PMP activities with the board. “CSA registration” means registration with the board under the Iowa uniform controlled substances act pursuant to 657—Chapter 10. “DEA number” means the registration number issued to an individual or pharmacy by the U.S. Department of Justice, Drug Enforcement Administration (DEA) authorizing the individual or pharmacy to engage in the prescribing, dispensing, distributing, or procuring of a controlled substance. “Dispenser” means a pharmacy or prescriber, regardless of location, who delivers to the ultimate user a substance required to be reported to the PMP. “Dispenser” does not include a person exempt from reporting pursuant to subrule 37.7(2). “First responder” means an emergency medical care provider, a registered nurse staffing an authorized service program under Iowa Code section 147A.12, a physician assistant staffing an authorized service program under Iowa Code section 147A.13, a firefighter, or a peace officer as defined in Iowa Code section 801.4 who is trained and authorized to administer an opioid antagonist. “Health care professional” means a person who, by education, training, certification, or licensure, is qualified to provide and is engaged in providing health care to patients. “Health care professional” does not include clerical or administrative staff. A health care professional shall be licensed, registered, certified, or otherwise credentialed in a manner that permits verification of the health care professional’s credentials. “Health care system” means an organization that includes at least one hospital or at least one group of practitioners that provides comprehensive care who are connected with each other through common ownership or management. “HIPAA” means the Health Insurance Portability and Accountability Act. “Law enforcement” means an entity or agency with jurisdiction to investigate or prosecute violations of criminal law. “Law enforcement” includes, but is not limited to, such agencies as police departments, United States attorneys, United States Drug Enforcement Administration (DEA), county attorneys, and the Medicaid Fraud Control Unit. “Licensing authority” means an agency that licenses or registers health care professionals with jurisdiction to enforce governing laws over those individuals who are licensed or registered. “Licensing authority” includes, but is not limited to, professional licensing boards and the United States Drug Enforcement Administration (DEA). “NarxCare” means an analytics tool and care management platform that helps practitioners analyze real-time data from the PMP. The platform analyzes patient data and history to provide a patient risk score and usage patterns to help practitioners identify potential risk factors. “NDC number” means the universal product identifier used in the United States to identify a specific human drug.

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“PMP administrator” means staff persons designated to manage and administer the PMP under the direction and oversight of the board and the council. “Practitioner” means a prescriber or a pharmacist. “Practitioner’s delegate” means a health care professional who is under the supervision of a PMP-registered practitioner and who is authorized by the practitioner to access PMP information on the practitioner’s behalf. “Prescriber” means an individual with an active CSA registration with the authority to prescribe controlled substances. For the purposes of this chapter, “prescriber” does not include a licensed veterinarian. “Prescription monitoring program” or “PMP” means the program established pursuant to these rules for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals. “Reportable prescription” means the record of a controlled substance administered or dispensed by a practitioner and the record of an opioid antagonist dispensed by a practitioner or administered by a first responder. “Reportable prescription” shall not include records identified in subrule 37.7(1). “Reportable prescription” shall include, but not be limited to:

the dispensing of a controlled substance to an emergency department patient;

the administration of a controlled substance to an emergency department patient at the discretion of the treating practitioner;

the administration or dispensing of an opioid antagonist to an emergency department patient;

the dispensing of a controlled substance sample; and

the dispensing of a controlled substance or opioid antagonist to a patient upon discharge from a hospital or care facility.

657—37.3(124) Registration. Registration for the PMP pursuant to this rule shall be via the Iowa PMP AWARxE website at iowa.pmpaware.net. 37.3(1) Prescribers. A prescriber shall register for the PMP at the same time the prescriber registers or renews a CSA registration pursuant to 657—Chapter 10. A licensed veterinarian with an active CSA registration may register for the PMP. 37.3(2) Pharmacists. A pharmacist who is involved in patient care shall register for the PMP at the same time the pharmacist becomes licensed or renews a license pursuant to 657—Chapter 2. 37.3(3) Practitioner delegates. A practitioner may authorize an adequate number of health care professionals that actively work with the practitioner to act as the practitioner’s delegates for the purpose of requesting PMP information. A practitioner’s delegate shall be licensed, registered, certified, or otherwise credentialed as a health care professional in a manner that permits verification of the health care professional’s credentials. The practitioner shall be responsible for the PMP information access of the practitioner’s delegates.

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37.3(4) Law enforcement officials. A law enforcement official may register for the PMP to access information by order, subpoena, or other means of legal compulsion relating to a specific investigation and supported by a determination of probable cause. 37.3(5) Licensing authority. A licensing authority official may register for the PMP to access information by order, subpoena, or other means of legal compulsion relating to a specific investigation and supported by a determination of probable cause. 37.3(6) Medical examiners and medical examiner investigators. A medical examiner or a medical examiner investigator may register for the PMP to access information when the information relates to an investigation being conducted by the examiner or investigator. 657—37.4 and 37.5 Reserved. 657—37.6(124) Security of PMP credentials. Each user registered to access PMP information shall securely maintain and use the login and password and any other secured credentials assigned to the individual user. Except in an emergency when the patient would be placed in greater jeopardy by restricting PMP information access to the user, a registered user shall not share the user’s secure login and password information. 657—37.7(124) PMP reporting – exemptions. 37.7(1) Exempted dispensing or administration. The dispensing or administration of a controlled substance as described in this subrule shall not be considered a reportable prescription. A pharmacy engaged in the distribution of controlled substances solely pursuant to one or more of the practices identified herein shall notify the PMP administrator of the exempted practice and the pharmacy shall not be required to report to the PMP. a. The dispensing by a licensed hospital pharmacy for the purposes of inpatient hospital care. b. The dispensing by a licensed pharmacy for a patient residing in a long-term care or inpatient hospice facility. c. The administration by a prescriber of a controlled substance for the purposes of outpatient procedures. 37.7(2) Exempted practitioners. The following shall not be required to report to the PMP and shall not be required to notify the PMP administrator of the exempted status of the practitioner: a. A licensed pharmacy that does not have a CSA registration and does not dispense controlled substances in Iowa. b. A licensed veterinarian who administers or dispenses a controlled substance in the normal course of the veterinarian’s professional practice. c. A DEA-registered narcotic treatment program which is subject to the record keeping provisions of 21 Code of federal regulations section 1304.24. 657—37.8(124) PMP reporting – dispensing prescribers. Each dispensing prescriber, unless exempt pursuant to rule 657—37.7(124), shall submit to the PMP a record of each reportable prescription dispensed during a reporting period pursuant to subrule 37.12(2). For purposes of prescriber dispensing, the prescriber shall also be identified as the dispenser or pharmacy.

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657—37.9(124) PMP reporting – pharmacies. Each pharmacy, unless exempt pursuant to rule 657—37.7(124), shall submit to the PMP either a record of each reportable prescription dispensed or administered during a reporting period pursuant to subrule 37.12(2) or a zero report pursuant to subrule 37.12(4), as appropriate. 657—37.10 and 37.11 Reserved. 657—37.12(124) Reporting requirements. 37.12(1) Data elements. The information submitted to the PMP for each reportable prescription shall be accurate and shall include, at a minimum, the following data elements: a. Dispenser DEA number. b. Date the prescription is dispensed or administered. c. Prescription number or unique identification number. d. NDC number of the drug dispensed or administered. e. Quantity of the drug dispensed or administered. f. Number of days of drug therapy provided by the drug dispensed or administered. g. Patient legal first and last names. h. Patient address including street address, city, state, and ZIP code. i. Patient phone number. j. Patient date of birth. k. Patient gender. l. Prescriber name and DEA number. m. Date the prescription was issued by the prescriber. n. Method of payment. o. Form of transmission of prescription origin. p. Refill number. q. Number of refills authorized. r. Indication as to whether the prescription is new or a refill. 37.12(2) Reporting periods. A record of each reportable administration or prescription dispensed shall be submitted by each dispenser no later than the next business day following administration or dispensing. 37.12(3) Transmission. Prescription dispensing and administration information shall be transmitted via the PMP’s current version of data upload or electronic submission. 37.12(4) Zero reports. If a pharmacy did not dispense or administer any reportable prescriptions during a reporting period, the dispenser shall submit a zero report no later than the next business day. 657—37.13(124) Opioid antagonist administration by first responders.

37.13(1) The administration of an opioid antagonist by a first responder shall be reported to the PMP, unless such administration was reported to the Iowa department of public health bureau of emergency and trauma services.

37.13(2) The reporting of the administration of an opioid antagonist by a first responder shall include the following data elements:

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a. Patient first and last names. b. First and last name of the individual who administered the opioid antagonist. c. Date of administration. d. Quantity of the opioid antagonist administered.

657—37.14 and 37.15 Reserved. 657—37.16(124) Access to PMP information. All information contained in the PMP is confidential and shall only be accessed as provided in this rule. All requests for PMP information must comply with the format specified by the board for the particular type of request. Once information is accessed, further dissemination or use of that information is governed by applicable federal and state laws governing the person who accessed the information. The board may charge a fee to recover the actual costs associated with responding to any request by a person other than a practitioner or a practitioner’s delegate. Any fees or costs assessed by the board shall be considered repayments receipts as defined in Iowa Code section 8.2. 37.16(1) Prescribers. A prescriber may access a patient’s prescription history report; the prescriber’s report card; proactive alerts or system user notes, such as peer to peer communication; and NarxCare reports. 37.16(2) Pharmacists. A pharmacist may access a patient’s prescription history report; proactive alerts or system user notes, such as peer to peer communication; and NarxCare reports. 37.16(3) Practitioner’s delegates. A practitioner’s delegate may access a patient’s prescription history report; proactive alerts or system user notes, such as peer to peer communication; and NarxCare reports. 37.16(4) Licensing authority officials. a. A licensing authority with jurisdiction over a practitioner may obtain the following information, if accompanied by a subpoena compelling disclosure of such information for a specific investigation into the prescribing or dispensing practices of the licensee: prescription history reports; proactive alerts or system user notes, such as peer to peer communication; PMP access logs and login records; and NarxCare reports. b. A licensing authority with jurisdiction over a health care professional may obtain the following information, if accompanied by a subpoena compelling disclosure of such information for a specific investigation into the licensee’s misuse of controlled substances: the licensee’s prescription history report.

37.16(5) Law enforcement officials. A law enforcement official may obtain a patient’s prescription history report if accompanied by a subpoena or other means of legal compulsion compelling disclosure of such information for use in a specific investigation. 37.16(6) Medical examiners and medical examiner investigators. A medical examiner or medical examiner investigator may obtain a decedent’s prescription history report for use in a specific investigation. 37.16(7) Patients. A patient or the patient’s agent may request the patient’s own prescription history report using the board’s patient request form. The request can be personally delivered to the board office where the patient will be required to present current government-

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issued photo identification at the time of the delivery of the request. A patient who is unable to personally deliver the request to the board office may submit a notarized request, along with a certified copy of the patient’s government-issued photo identification, via mail or commercial delivery service. The following agents may submit a request on behalf of a patient: an individual with a medical power of attorney for the patient, a patient’s attorney, or an executor of the patient’s estate. In addition to the patient’s information, the patient’s agent shall be identified by name, current address, and telephone number. In lieu of the patient’s signature and identification, the patient’s agent shall sign the request and the government-issued photo identification shall identify the patient’s agent. The patient’s agent shall include a copy of the legal document that establishes the agency relationship with the patient. 657—37.17(124) Integrated systems. A practitioner or a health care system may integrate its electronic health record system with the PMP using an application programming interface. Use of an integrated system shall comply with all of the following: 1. The integrated system shall log each user’s access to PMP information. Access logs shall be retained by the practitioner or health care system for a minimum of four years from the date of access and shall be provided to the board upon request. 2. If the user identified in access logs is not the practitioner, the integrated system shall clearly identify on which practitioner’s behalf the user was accessing PMP information. A practitioner’s delegate using an integrated system is required to maintain active PMP registration. 3. The integrated system shall maintain appropriate administrative, technical, and physical security measures to safeguard against unauthorized access, disclosure, or theft of PMP information and shall meet all HIPAA requirements for safeguarding protected health information. 4. The practitioner or health care system shall notify the PMP administrator of any breach in the electronic health record system that may have included PMP information within 72 hours of making the determination that a breach occurred. 5. An integrated system shall comply with all requirements in Subchapter VI of Iowa Code chapter 124 and all requirements of this chapter. 657—37.18(124) PMP administrator access. 37.18(1) PMP staff. The board may designate PMP administrators who may access any PMP information needed to perform the functions of the job.

37.18(2) Statistical data. The PMP administrator or designee may provide summary, statistical, or aggregate data to public or private entities for statistical, public research, public policy, or educational purposes. The board may charge a fee to recover the actual costs associated with responding to a request for PMP data pursuant to this subrule. Any fees or costs assessed by the board shall be considered repayments receipts as defined in Iowa Code section 8.2. 657—37.19 and 37.20 Reserved.

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657—37.21(124) Record retention. The PMP shall retain all reported prescriptions and all records of access to or query of PMP information for a minimum of four years from the date of the record. 657—37.22(124) Information errors. Any person who believes that PMP information is erroneous shall notify the pharmacy or dispensing practitioner. Upon notification of a potential error in PMP information, the pharmacy or dispensing practitioner shall promptly correct erroneous information in the record. 657—37.23(124) Discipline. Any licensee who fails to comply with the provisions of the law or these rules is subject to disciplinary action by the board. These rules are intended to implement Iowa Code sections 124.550 to 124.554, as amended by 2018 Iowa Acts, House File 2377; 124.551A as created by 2018 Iowa Acts, House File 2377; 124.555; and 124.556 to 124.558, as amended by 2018 Iowa Acts, House File 2377.

ADDENDUM J

SETTLEMENT AGREEMENT AND FINAL ORDER

SHEILA SCHLEEPER PHARMACIST LICENSE NO. 23200

BURLINGTON

NOVEMBER 14, 2018

BEFORE THE IOWA BOARD OF PHARMACY

RE:

Pharmacist License of

SHEILA SCHLEEPER

License No. 23200Respondent

SETTLEMENT AGREEMENT ANO

TINAT ORDER

Pursuant to lowa Code sections 17 A.72(51 and 272C.3(41 l2o77l, and 657 IAC 35.24, thelowa Board of Pharmacy ("Board") and Sheila Schleeper ("Respondent") enter into the followingSettlement Agreement and Final Order ("Order") to settle a contested case currently pending

before the Board.

The allegations contained in the Statement of Charges against Respondent shall be

resolved without proceeding to hearing, as the Board and Respondent stipulate as follows:

1. The Board filed a Notice of Hearing and Statement of Charges on September 18, 2018

2. The Board has jurisdiction over the parties and the subject matter of these proceedings

3. Respondent acknowledges that allegations contained in the Statement of Charges, ifproven in a contested case proceeding, would constitute grounds for the discipline agreed to inth is Order.

4- Execution of this Order constitutes the resolution of a contested case. Respondent has a

right to hearing before the Board on the charges, but Respondent waives the right to hearing and

all attendant rights, including the right to appeal or seek judicial review of the Board's actions,

by freely and voluntarily entering into this Order. Once entered, this Order shall have the forceand effect of a disciplinary order entered following a contested case hearing.

5. Respondent acknowledges that she has the right to be represented by counsel on thismatter.

6. Respondent agrees thatthe State's counsel may present this Order to the Board a nd may

have ex porte communications with the Board while presenting it.

7. This Order is subject to approval by a majority of the full Board. lf the Board does not

approve this Order, it shall be of no force or effect to elther party, and shall not be admissible forany purpose in further proceedings in this matter. lf the Board approves this Order, it shall be

the full and final resolution of this matter.

CASE NO. 2078-82

REEE I}iEDocT 2 5 2018

IOWA BOARD OF PHARMACYPage 1 of 2

8. ThisOrdershall be part of Respondent's perma nent record and sha ll be consid ered by theBoard in determining the nature and severity of any disciplinary action to be imposed in the eventof any future violations.

9. ThisOrdershall not be bind ing as to any new complaints received by the Board.

10. Respondent u nderstands the Board is req uired by federal law to report any adverse actionto the NationalAssociation of Boards of Pharmacy's Disciplinary Clearinghouse and the NationalPractitioner Data Bank.

11. This Order, when fully executed, is a public record and is available for inspection and

copying in accordance with the requirements of lowa Code chapters 22 and 272C.

L2. The Board's approval of this Order shall constitute a FINAL ORDER cf the Board.

13. Respondent is hereby CITED for having disciplinary action taken against her license by a

licensing authority in another state and WARNED that Respondent's failure to comply with thelaws governing the practice of pharmacy in the future could result in further discipline.

14. Respondent shall participate in the lowa Monitoring Program for Pharmacy Professionals

(lMP3). Respondent's failure to comply with the requirements of the lMP3 shall be considered a

violation of this Order.

15. Should Respondent violate the terms of this Order, the Board may initiate action toimpose other licensee discipline as authorized by lowa Code chapters L47, L55A, and 272C and

657 IAC chapter 36.

lo 0.0 itA

SHEILA SCHLEEPER

Respondent

This Settlement Agreement and Final Order is approved by the lowa Board of Pharmacy on

No*"**.r--, N , 2018.

Chairpersonlowa Board of Pharmacy

Page 2 of 2

IT IS THEREFORE ORDERED:

ADDENDUM K

COMBINED STATEMENT OF CHARGES, SETTLEMENT AGREEMENT, AND FINAL ORDER

RUSSELL ENGLAND, MD

CSA REGISTRATION NO. 1208110 FAIRFIELD

NOVEMBER 14, 2018

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BEFORE THE IOWA BOARD OF PHARMACY

cAsE NO.2018-69RE:

Controlled Substances Act Registration of

RUSSEU ENGI.AND, MDRegistration No. 1208110Respondent

COMSINEO STATEMENT OF CHARGE5,

SETTTEMENT AGREEMENT, AND FINALORDER

COME NOW the lowa Board of pharmary l,,Board,,l and Russell England, MD,("Respondent''), 2709 W Briggs Ave, Ste 4, Fairfield tA 52556, and enter inro this CombinedStatement of Charget Settlement Agreement, and Final Order (,,Order,,) pursuant to lowa Codeseetions 17A.x0, 124,305, and 272c.3(4) (2018). The Board hasjurisdiction over Respondent andthe subject matter ofthis case pursuafit to lowa code chapters l7A, L24, and Zlzc, and 5s7 IACchapter 10.

A, STATEMENTOFCHARGES

COUNT I

DISCIPTINARY ACNON A6AINST PROFESSIONAT. UCENSE

1, Respondent is charged with having his professional license disciplined in a way thatresricts his ability to handle or prescribe controlled substanEes, pursuant to lowa Code section12a.30a(1)(e) and 557 tAC 10.10(1)"e",

B. FACIUALCIRCUMSTANCE5

2. Respondent holds lowa Controlled Substances Act (CSA) registration number 12081,X0,

which is currently active through August 31, 2019.

3. 0n June 8, 2018, the lowa Board of Medicine approved a Combined Statement of Charges

and Settlement Agreement that imposed discipline on Respondent's medical license for improperpain management. Under the Agreement, Respondent is prohibited from prescribing,

administering; or dispensing controlled substances for the treatment of chronic pain.

Respondent's medical license was also placed on probation for a period of 3 years.

C. SETTLEMENT AGREEMET{T AND FINAT ORDER

4, The Board has jurisdiction over the parties and the subject matter of these proceedin8s.

5. Respondent acknowledges that the allegations in the Statement of Charges, if proven in

a contested case hearing would constitute Brounds for the discipline agreed to in this Order.

6. Execution of this Order constitutes the resolution of a contested case. Respondent has a

Page 1 of 3

?018-11-02 15'3? Chautauqua CIinic 6412096690 >> 5152814609 P 1/5

right to a hearing before the Board on the charges, but Respondent waives the right to hearingand all attendant rights, inctuding the right to appeal or seek judicial review ofthe Board,s action,by freely and voluntarily entering into this Order. Once entered, this Order shall have the forceand effect of a disciplinary order entered following a contested case hearing.

7. Respondent acknowledges that he has the ritht to be represented by counsel on thismatter.

8. This Order is subject to approval by a majority of the full Board. lf the Board does notapprove this Order, it shall be of no force or effect to either party, and shall not be admissible forany purpose in further proceedings in this matter. lf the Board approves this order, it shall bethe full and final resolution of this matter.

9. This Order shall be pan of Respondent's permanent record and shall be considered by theBoard in determining the nature and severity of any disciplinary action to be imposed in the eventof any future violations,

10. Respondent understands the Eoard is required by federal law to report any adverse actionto the National Association of Boards of Pharmaqy's Disciplinary Clearinghouse and the NationalPractitioner Data Bank.

11. This Order, when fully executed, is a public record and is available for inspectjon andcopying in accordance with the requirements of lowa Code chaple'sZZ and 272C,

12. The Board's approval of this Order shall constitute a FTNAL ORDER of the Board.

IT IS THEREFORE ORDERED:

13. Respondent's CSA registration is hereby RESTRICIED to prohibit Respondent fromprescribing, administerin& or dispensing controlled substances for the treatment of chronic pain

as defined by the lowa Board of Medicine.

14. lf the lowa Board of Medicine permits Respondent to prescribe, adminifier, or dispense

controlled substances for the treatment of chronic pain in the future. Respondent shall notify thelowa Board of pharmacy. Respondent's CSA registration shall remain resticted until such

notification occurs.

15. Respondent shall comply with all terms and conditions of the lowa Board of Medicine's

probation. Respondent shall report any violations of his probation to the lowa Board of

Pharmacy immediately,

16, Respondent shall provide a copy of this Order to all employers,

17.Should Respondent violate the terms of this Order, the Board may initiate action tosuspend or revoke Respondenfs CSA registration as authorized by lowa Code chaPter 124 and

657 IAC chapter 10.

Page 2 of 3

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This Combined Statement of Charges, Settlement Agreement, and Final Order is voluntarilysubmitted by Respondent to the Board for its consideration on the llt day ofw 2018.

't"*"(eG-rFRUSSELL ENG

Respondent

uqEdMD

This Combined Statement of Charges,

lowa Board of Pharmacy on ttre\S a

t Agreement, and Final order is approved by the2018.

21.4r.1<

ay of

Chairperson

lowa Board of Pharmacy

Page 3 of 3

r'r-r^

ADDENDUM L

COMBINED STATEMENT OF CHARGES, SETTLEMENT AGREEMENT, AND FINAL ORDER

TARA BEVANS

PHARMACY SUPPORT PERSON REGISTRATION NO. 5363 WATERLOO

NOVEMBER 14, 2018

fr+fN4u oq

sIS -BE OR THE IOWA BOARD O PHARMACY

.201&95

ED STATEMENf OF CHARGES,

ENI AGREEMENT, AND FINAT

ard of Pharmac) "Board") and Tara (Newell) Bevans

RE:

Pharmacy SupPort Person R

TARA (NEWELLI BEVANS

Registratlon No, 5363

Respondent

COME NOW the I

("Respondent"), 805 Hawta

orn Ave, Waterloo lA 702, and enter into this Comblned

Sta tement of ch'arges, Settl en ABteement, and-Fttal er ("OrderJ pursuant to lowa Code'

sections 17A.10 and 272C.3

and the subject matter ofthand 657 IAC chaPter 36.

),a d 657 IAC 35.5. The rd has jurisdiction over Respondent

ca5 pu rsua nt to lowa Co chapters 17A, 1554, and 272C (2018),

STAIEMENT OF ARGES

COUNT I

DI ERTING PRESCRIPTI DRUGS

1. Respondent is cha h divertlng plescriPt

disciplined Pursuant

n drugs from a pharmacy for personal

use or for dlstributlon, and

rAC 36.5(37),

ay lowa Code section 155A,68(5) and 657

B TACfUAL CIRCU NCES

2. ResPondent's lowa P arm cy su pport Person I ration number 5363 is currently actlve

through December 31, 20

3. ln August 2018, Re

- place of-emPloyment'

c.

on nt diverted approxi ly 60 caPsules of VYvanse from her

LEMENT AGREEMEN D FINAL ORDER

4. The Board has Juris ctio over the Parties and e subject matter of these proceedings'

5. ResPondent ackn ed s th at the allegations the Stetement of Charges, if proven in

a contested case hearing' uld nstitute grounds fo he disciPllne agreed to in this Order.

6. Execution of this Or er es the resoluti of a contested case. Respondent has a

right to heering beforo the on the charges, but R pondent waJes the right to hearing and

right to aPPeal or se judicial review of the Board' s action, bY

A.

5E

a

all attendant rights, includi gththls Order. Once e

e force and

freely and volunta rilY ente

88:91 Bl0z/tt/lt

CASE N

COMBISETTLE

ORDEi

gist atio n of

i00/200 d zs80*

n8i

Page 1 of 3

ered, this order shall have th

fix

effect of a disclpllnary order nter

7. Respondent acknowmatter.

8. Respondent agrees

ges

thhave ex porte communicatio s witr

9. Thls Order is subject

approve this Order, it shall b

any purpose in further proc

oaqof nl

the full and final resolution th is

10. This order shall be P of!

edlni

Board in determining the n

of any future violations.

11. Respondent u nder

re ai

Or rl

B"l

12. This Order, when fu EX

copying in accord ance with erq

13. The Board's aPProva of

IT IS THE R

14. Respondent agrees to1attdregistration to resolve thls

dccepted bY the Board, has

rAc 35,8.

15, Respondent agrees o_t_to

es

retsupport Person re8istration

rAc 3s.36.

lmpose other llcensee di

IAC chapter 36.

16. Should ResPonden v iold

line

t

r

,00 /800 d zsSe#

Page 2 of 3

88:9f 8l0Z/el/ll

d following a conte

hat she has the rig

d case hea rlng.

to be represented by counsel on thls

[s in this matter. lf tmatter.

[espondent's Perman t record and shall be considered by the

Id severlty of anydlsci nary act ion to be imposed lnthe erienl

re Board is required b deral law to report any adverse action

rds of Pharmacy's Di plinary Clearinghouqe and the National

fstate's cou nsel mav

h the Board while pre

proval by a majorltyb force or effect to eit

ecuted, is a Public r

Quirements of lowa

is order shall con

work ln e PhermacY in

liit.i"d. nny request

te the terms of this

as authorized bY low

sent this Order to the Board and may

ntinB it.

the full Board. lf the Board does not

r party, and shall not be admisslble forBoard approves this Order, it shall be

rd and is available for inspection and

e chapters 22 and 772c.

a FINAL ORDER of the Board

04^4

TARA (N ELL) BEVANS

Respon

nv capacitY in lowa unless her pharmacy

, r."initrt.r"nt *ill be governed bY 657

rder, the Board may initiate action to

Code chapters 155A and 272C and 657

i/OLUNTARILY SURR DER her PharmacY support Person

This volu ntarY su rr nder ls consldered discipline and, when

[me force and effect an order of revocation pursuant to 657

t

to the National Association

Practitioner Data Bank.

rn

This Combined Statement oflowa Board of Pharmacy on e

ha

day of

t00/r00 d z98ei

Page 3 of 3

68:9! SIAZ/El/ll

Settlement Agree t, and Final Order ls apploved bythee(f\ 20L8,

Chairpersolowa Board Pharmecy

ADDENDUM M

FINDINGS OF FACT, CONCLUSIONS OF LAW, DECISION, AND ORDER

CHRISTOPHER BETTS

PHARMACIST LICENSE NO. 19918 URBANDALE

NOVEMBER 14, 2018

BEFORE THE IOWA BOARD OF PHARMACY ____________________________________________________________ IN THE MATTER OF: ) ) Docket No. 2017-146 Pharmacist License of ) DIA No. 19PHB0002 CHRISTOPHER BETTS ) License No. 19918, ) FINDINGS OF FACT, ) CONCLUSIONS OF LAW, Respondent. ) DECISION, AND ORDER ) ____________________________________________________________

STATEMENT OF THE CASE On July 24, 2018, the Iowa Board of Pharmacy (Board) found probable cause to file a Notice of Hearing and Statement of Charges against Respondent Christopher Betts, alleging one count: Failure to Ensure Legal Operation. The hearing was held on September 18, 2018. The following members of the Board presided at the hearing: Sharon Meyer, Chairperson; LaDonna Gratias; Edward McKenna; Jason Hansel; Gayle Mayer; Brett Barker; and Joan Skogstrom. Assistant attorney general Laura Steffensmeier represented the State. Respondent Christopher Betts appeared and was self-represented. The hearing was open to the public at Respondent’s request, pursuant to Iowa Code section 272C.6(1). The hearing was recorded by a certified court reporter. Administrative Law Judge Laura Lockard assisted the Board in conducting the hearing and was instructed to prepare the Board’s written decision in accordance with its deliberations.

THE RECORD The record includes the Notice of Hearing and Statement of Charges. The record also includes hearing testimony of Jean Rhodes and Christopher Betts. State’s Exhibits 1 through 8 were admitted as evidence. Respondent’s Exhibit A was also admitted as evidence. At the State’s request, State’s Exhibits 3 and 4 and Respondent’s Exhibit A are subject to a protective order based on patient information contained therein.

FINDINGS OF FACT Respondent Christopher Betts is a pharmacist licensed in the state of Iowa. At all times relevant to this matter, Respondent was the pharmacist in charge (PIC) at CVS Pharmacy #10162, located in Des Moines, Iowa. In June 2017, Patient A filled a prescription for temazepam, a controlled substance, at Respondent’s pharmacy. The prescription label reflected that Dr. Jennifer Gerrietts was the prescriber, which was incorrect. The actual prescriber was Nguyen-Ly Huynh, PA-C. At the time that the prescription was initially filled, CVS’s computer system used a drop-

DIA No. 19PHB0002 Page 2

down menu to show prescribers who had previously written prescriptions for a particular patient; the person inputting the prescription into the CVS system selected from this menu in order to indicate who the current prescriber was. As Dr. Gerrietts was the primary care provider for Patient A, she showed up in the drop down menu and was incorrectly selected as the prescriber. (Exh. 3; Betts testimony). When Patient A requested a refill of the prescription in September 2017, pharmacy personnel discovered that the prescription had initially been filled with the wrong prescriber, Dr. Gerrietts, listed in the computer system and on the label. At the time of refill, the CVS computer system does not allow the prescriber field to be edited. When Respondent was made aware of the error regarding Patient A, he contacted CVS management and asked how to edit the prescription in order to reflect the correct prescriber. Respondent was told that editing the prescriber was not possible and that he would need to delete the original entry and input the original prescription again with the correct prescriber information. Respondent did this, and made a note in the computer record that the fill on June 3, 2017 was done with the wrong doctor listed.1 (Betts testimony; Exh. A). In October 2017, Dr. Gerrietts became aware of the error when Patient A came in to see her to refill medications and brought the bottle of temazepam with her name on it. Dr. Gerrietts contacted the pharmacy and spoke with Respondent, who acknowledged the error and informed her that the system had been changed to remove her name as the prescribing doctor. Dr. Gerrietts subsequently filed a complaint with the Board. (Exh. 5, pp. 8-10). As part of the Board’s investigation of the complaint, Board compliance officer Jean Rhodes requested that Respondent provide her a copy of the continuous quality improvement (CQI) program report that was completed regarding this error. The pharmacy had a computer program that existed to document errors at the time, but there was no specific category for an error that resulted in the wrong prescriber being listed on the medication label; such an error was labeled an error and recorded in the pharmacy’s computer system only if it had an adverse effect on the patient. Owing to the configuration of the computer system, Respondent did not make a report regarding the labeling error immediately upon discovering the error. When Rhodes contacted Respondent and inquired about the CQI report, Respondent agreed with Rhodes that a labeling error was a dispensing error that needed to be reported under the pharmacy’s CQI program. At that time, he made a report in Respondent’s computerized error recording system. He informed Rhodes of this, but was not able to print a copy for her of the report as the system did not allow the option to print. When Respondent tried to print the report, all fields blacked out; he was

1 After being instructed by corporate management that editing the original prescription was impossible, Respondent considered making a duplicate entry so that the original information would not be lost. Respondent rejected this idea, however, out of concern that it could cause problems under the prescription monitoring program with Patient A’s providers believing he was obtaining the same controlled substance from two different providers at the same time.


likewise unable to copy and paste the report into another document in order to make it available to Rhodes. Respondent made the pharmacy’s management aware of this issue and Respondent’s immediate supervisor informed him that he did not believe the Board was entitled to the CQI report. (Betts testimony). Rhodes then attempted to obtain the CQI report through CVS’s corporate management. The pharmacy’s corporate management ultimately sent Rhodes an e-mail on February 13, 2018 that contained information regarding the incorrect labeling event that occurred on June 3, 2018. Respondent testified at hearing that what was sent to Rhodes in the e-mail was not the text from the CQI report he completed; it appeared to him to be a paraphrase of information that he input into the computer record. Rhodes noted that the CQI report did not include a date and time that the event was discovered. That information was part of the CQI report that Respondent filled out electronically; he does not know why it was not included when the pharmacy’s corporate management sent the report to the Board. (Betts, Rhodes testimony; Exh. 4, p. 27). Since this error occurred, Respondent has learned through experience that a prescription entry can be edited at the time of refill by refunding the refill at the register, which allows him to edit the original entry. Respondent was unaware of this process at the time, and CVS management, from whom he sought assistance, did not provide him this information. This process is how Respondent will deal with any future errors, so that the original information is preserved in the computer system for review. (Betts testimony). The pharmacy has also changed its CQI policies and procedures to include the maintenance of a paper record of reportable events that can be immediately available to the Board for inspection. The paper record is reviewed quarterly by Respondent, as PIC, and by Respondent’s district manager, to ensure that appropriate remedial steps have been taken for any errors and to improve performance going forward. (Betts testimony). Additionally, the pharmacy has now changed its computer system so that there is no option to autopopulate the prescriber on a new prescription. The prescriber must be entered manually each time a new prescription is input, thus reducing the opportunity for labeling errors such as the one that occurred here. (Betts testimony). Board Action against CVS Pharmacy #10162 In July 2018, the Board charged CVS Pharmacy #10162, the pharmacy at which Respondent works as PIC, with failing to have a CQI program that complies with the requirements of 657 Iowa Administrative Code 8.26. The factual allegations in the Statement of Charges against the pharmacy are nearly identical to the factual allegations in the Statement of Charges against Respondent. As part of a settlement agreement, the pharmacy admitted the factual allegations contained in the Statement of Charges. The pharmacy was cited for having a noncompliant CQI program and ordered to pay a $2,500 civil penalty. The pharmacy was also required to retrain all pharmacy staff on its updated CQI program policies and procedures. (Exh. 7).


CONCLUSIONS OF LAW

Pursuant to Iowa Code section 155A.12(1), the Board may impose discipline on a pharmacist’s license in the event that the licensee violates any provision of Chapter 155A or any rules of the Board adopted under Chapter 155A.2 Under the Board’s rules, a pharmacist in charge is tasked with working cooperatively with the pharmacy, by and through its owner or license holder, and with all staff pharmacists to ensure the legal operation of the pharmacy, including meeting requirements of state and federal laws, rules, and regulations governing the practice of pharmacy.3 Continuous Quality Improvement Program The Board’s regulations require that a pharmacy, its PIC, and all staff pharmacists share responsibility for establishing, implementing, and utilizing an ongoing, systematic program of continuous quality improvement for achieving performance enhancement and ensuring the quality of pharmaceutical services. The rules identify the pharmacy and the PIC as sharing responsibility for establishing the CQI program.4 The CQI program is an ongoing, systematic program of standards and procedures aimed at detecting, identifying, evaluating, and preventing medication errors with the ultimate goal of improving medication therapy and the quality of patient care.5 Under a CQI program, any preventable medication error resulting in the incorrect dispensing of a prescribed drug received by or administered to the patient must be recorded. Such events include, but are not necessarily limited to:

a. An incorrect drug; b. An incorrect drug strength; c. An incorrect dosage form; d. A drug received by the wrong patient; e. Inadequate or incorrect packaging, labeling, or directions; or f. Any incident related to a prescription dispensed to a patient that

results in or has the potential to result in serious harm to the patient.6

The Board’s regulations require that all CQI records be maintained on site at the pharmacy or be accessible at the pharmacy and available for inspection and copying by the Board or its representative for at least two years from the date of the record.7 The specific allegation against Respondent in this case is that he failed to ensure legal operation of a pharmacy by failing to have a continuous quality improvement program 2 See also 657 Iowa Administrative Code (IAC) 36.6(21). 3 657 IAC 8.3(1). 4 657 IAC 8.3(5)(c). 5 657 IAC 8.26. 6 657 IAC 8.26(1). 7 657 IAC 8.26(5).


that complies with the requirements of 657 Iowa Administrative Code 8.26. Under the circumstances, the Board concludes that Respondent has not committed the violation alleged. Under the Board’s regulations, the PIC and the pharmacy share responsibility for ensuring legal operation of the pharmacy, which includes establishing the CQI program. The Board appreciates the realities of a PIC who is working inside a corporate structure over which he or she does not exert direct control. In this situation, Respondent took immediate action after learning the error had been committed and promptly sought input from management as to how to properly identify the error in the pharmacy’s computerized systems. The limitations of the computerized reporting system led to a delay in Respondent making a written CQI report of the error, but he took steps to ensure that the issue was addressed, including changing the label on the refill to reflect the correct prescriber and ensuring that the fill history, including the error, was documented in the pharmacy’s prescription system. Additionally, Respondent took appropriate and prompt action to respond to the Board’s inquiries and to make his superiors aware of the inquiries where he was not empowered to provide information directly. Ultimately, Respondent’s actions – along with the Board’s intervention directly with the pharmacy – resulted in an improved CQI system that more effectively addresses patient safety. Had Respondent taken less robust steps in addressing the error and communicating his concerns to the pharmacy directly, the result may well have been different here.

DECISION AND ORDER

IT IS THEREFORE ORDERED that the Statement of Charges filed against Christopher Betts on July 24, 2018 is hereby DISMISSED. Dated this 14th day of November, 2018.

Sharon Meyer Chairperson, Iowa Board of Pharmacy cc: Laura Steffensmeier, Assistant Attorney General Christopher Betts, Respondent Any aggrieved or adversely affected party may seek judicial review of this decision and order of the board, pursuant to Iowa Code section 17A.19.

State of Iowa Board of Pharmacy

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