Pharmacy Issues Under RCRA

P-Listed Pharmaceuticals

Todd HoutsDirector, EHSUniversity of Missouri

Introduction

A 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.

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.

Source: RCRA Online #14827

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.

Source: RCRA Online #14827

More on 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.

Source: RCRA Online #14827

Some Real World Examples

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

Blister Packs: What is counted?

A pill remaining in the blister pack or taken out but not administered would be unused.

The blister pack itself, and the backing is also unused.

Loose Pills: What is counted?

Residues in a pill bottle are unused.

Pill cutting residues should be collected. They are unused.

Dose cups: What is counted?

Guidance regarding dose cups varies by state.

A conservative approach is to assume there are unused residues.

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

IV Systems: What is counted?

IV Needles IV Bag and Tubing

Medication remaining in IV Bags is considered unused even if some portion of the drug was dispensed to the patient. The tubing and syringe are considered used.

Management Techniques

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.

Color Coded Waste Containers

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.

Source: RCRA Online #14827

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 Missourihoutst@missouri.edu

There are additional slides in this presentation – which will be made available to you by the organizers of this conference – that give more information and specific guidance. They were not presented in order to focus on the issues more broadly applicable.

Technical Clarifications

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

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.

Source: RCRA Online #13718

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.

Any potential characteristic codes might still apply.

Source: RCRA Online #14778

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.

Any potential characteristic codes might still apply.

Source: RCRA Online #14831

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.

Any potential characteristic codes might still apply.

Source: RCRA Online #14788

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.

Source: RCRA Online #14654