This document discusses P-listed pharmaceutical wastes and their potential to change a generator's status under RCRA regulations. P-listed materials like unused residues in packaging from medications like warfarin and epinephrine are of particular concern. The document provides guidance on estimating quantities of these residues and how they are treated under hazardous waste regulations.

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

4.  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

5.  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.

6.  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

7.  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

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

10.  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.

11. Residues in a pill
bottle are unused.
Pill cutting residues
should be collected.
They are unused.

12.  Guidance regarding
dose cups varies by
state.
 A conservative
approach is to assume
there are unused
residues.

13. 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

14. IV Needles IV Bag andTubing
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.

16.  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.

18.  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

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

20. Todd Houts
Director, EHS
University of Missouri
houtst@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.

22.  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

23.  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

24.  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

25.  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

26.  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

27.  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