P-Listed Pharmaceuticals--Pharmacy Issues Under RCRA; Houts, Todd; University of Missouri; 2014 Mid-America Environmental Compliance Seminar in Overland Park, KS, April 3-4

Pharmacy Issues Under RCRA

P-Listed Pharmaceuticals

Todd HoutsDirector, EHSUniversity of Missouri

IntroductionA basic understanding of RCRA is assumed in this presentation.

The EPA has recognized U- or P-listed pharmaceutical wastes as a potential source of non-compliance.

P-listed materials are of particular concern because of their potential to change Generator Status.

P-Listed Pharmaceuticals Arsenic trioxide (Trisenox) - P012 Epinephrine (Adrenaline) - P042 Nicotine - P075 Nitroglycerin - P081 Phentermine - P046 Physostigmine - P204 Physostigmine salicylate - P188 Warfarin (Coumadin) >0.3% - P001

More About Warfarin

Unlike most hazardous waste codes, the P001 code is concentration driven.

Only unused formulations which contain warfarin at a concentration greater than 0.3% are P-listed.

Below 0.3% the U248 code applies.

Source: RCRA Online #14827

Pharmaceutical Containers Blister Packs, Bingo Cards, Unit Dose

Packaging IV Bags and Tubing Ampoules (Physostigmine) Nicotine patch wrappers Bottles Syringes Dose Cups

Only the Residues Count

Any residue remaining in a container or in an inner liner removed from a container that has held any commercial chemical product . . .

The weight of the packaging itself does not count toward generator status.


Measuring Residues

CESQG’s and SQG’s who are in danger of exceeding 1 kg of P-listed materials may feel a greater incentive to measure or estimate.

If estimation is used, be prepared to defend your rationale.

Why Measure Only Residues? One retail pharmacy found an

“empty” 100 count bottle of 10 mg Coumadin w/o cap weighed 10 g. It would only take 100 bottles to be an LQG if you count the container.

But they found there is approximately 1 mg of residue in that bottle. It would take 1,000,000 bottles to be an LQG.


Examples of Residues

Another study found that for single dose packaging (blister packs) the maximum detectable quantity was 0.0358 mg of residue.

Still, RCRA requires collection of that virtually empty blister pack.


Nicotine Patches: What is counted?Outer Packaging Backing and Patch

Container: Outer packaging and the backing (RCRA)Where is virtually all of the nicotine?

A: In the patch. (Non-RCRA after use)Source: RCRA Online #14817

LQG’s Should Not Estimate Once LQG Generator status has been

reached there is no longer any incentive to make estimates regarding residual quantities of acute wastes.

Counting the weight of container and the residue is permissible and more conservative.

CSEQG’s and SQG’s may feel pressure to generate less than 1 kg of acute waste.

Some Regulatory Relief

Epinephrine Syringe Clarification Provided regulatory relief Epinephrine residues remaining in a

syringe after the proper dose is injected in a patient are not regulated as P042.

Any potential characteristic codes might still apply.


Epinephrine Salts

The scope of hazardous waste listing P042 does not include salts of epinephrine (the most common pharmaceutical form).

Only the free base of epinephrine and it’s associated empty containers are listed.



Phentermine Salts

The scope of the hazardous waste listing P046 does not include salts of phentermine.

Only the free base of phentermine and it’s associated empty containers are listed.



Syringe Clarification Extended

The interpretation that epinephrine residues remaining in syringes after the dose has been administered are not P-listed was extended to other pharmaceuticals on the P- and U-lists.



Medicinal Nitroglycerine

The acutely hazardous code for nitroglycerine is applied only when the material displays the characteristic of reactivity.

Medicinal formulations of nitroglycerine do not display the characteristic of reactivity, and therefore do not receive the P081 code when discarded.


Miscellaneous Notes

Shipping P-listed Residues The manifest only needs to reflect

the weight of the residues. Most shipping companies request

that the total weight be listed. If the shipping company requests the

total weight on the manifest, use box 14 to note that the weight of the containers was not included in determining generator status.


Potential Problem Areas

Guidance regarding dose cups varies by state. A conservative approach is to ship these items as hazardous waste.

Pill cutting residues should be collected and managed as hazardous waste.

Medication remaining in IV Bags is considered unused even if some portion of the drug was dispensed to the patient.

Differences in Authorized States Several states have provided their

own guidance* regarding pharmaceutical related packaging but none in Region VII

*Colorado, Massachusetts, Michigan, Minnesota, Washington

Questions?

Todd HoutsDirector, EHSUniversity of [email protected]