This presentation discusses P-listed pharmaceutical wastes and their potential to change a generator's status under RCRA. Specific P-listed drugs are identified including arsenic trioxide, epinephrine, nicotine, nitroglycerin, phentermine, physostigmine, physostigmine salicylate, and warfarin above 0.3%. Regulations regarding waste determination, containers, and manifesting are reviewed. Clarification is provided for epinephrine, phentermine, nitroglycerin, and other pharmaceutical residues and containers. State-specific guidance varies for items like dose cups and pill cutter residues.

1. P-Listed Pharmaceuticals
Todd Houts
Director, EHS
University of Missouri

2. 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.

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

4.  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

5.  Blister Packs, Bingo Cards, Unit Dose
Packaging
 IV Bags andTubing
 Ampoules (Physostigmine)
 Nicotine patch wrappers
 Bottles
 Syringes
 Dose Cups

6.  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

7.  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.

8.  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

9.  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

10. 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

11.  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.

13.  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

14.  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

15.  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

16.  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

17.  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

19.  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

20.  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.

21.  Several states have provided their own
guidance* regarding pharmaceutical related
packaging but none in RegionVII
*Colorado, Massachusetts, Michigan, Minnesota, Washington

22. Todd Houts
Director, EHS
University of Missouri
houtst@missouri.edu