This document provides information on the new EPA regulations for managing hazardous waste pharmaceuticals under 40 CFR Part 266 Subpart P. It discusses key definitions like non-creditable, potentially creditable, and evaluated hazardous waste pharmaceuticals. It also outlines the new management standards for generators, including training requirements, container standards, accumulation time limits, and shipping requirements for non-creditable and potentially creditable hazardous waste pharmaceuticals. The document aims to help healthcare facilities understand the changes from the old rules and ensure compliance with the EPA's new hazardous pharmaceutical waste rule.

2. Destruction of Controlled
Substances
Record Keeping Requirements

3. §1304.21 (e)
• Registrants must keep records of destructions
(§1317.95(c)(d)

4. §1317.15(d)
• Reverse Distributors

5. §1317.90
• Destroyed in compliance with all laws

6. §1317.95
• Transfer to registered person for destruction

9. §1317.60
• Inner Liner Requirements- waterproof, tamper evident and
tear-resistant.

10. Contact Information
• juana.m.hill@usdoj.gov

11. Ensuring Compliance with the
EPA’s New Hazardous
Pharmaceutical Waste Rule
Mike Maffuccio, EHS Practice Director – New York
Triumvirate Environmental

12. Agenda
12
Background
Definitions
Management Standards
Generator Programs
Q&A

13. RCRA and Healthcare
• The Resource Conservation and
Recovery Act of 1976:
▪ Originally conceived as a law
addressing municipal trash disposal,
Subtitle C of RCRA was included to
give the U.S. Environmental Protection
Agency (EPA) the authority to regulate
hazardous waste. This includes the
generation, transportation, treatment,
storage, and disposal of hazardous
waste
13

14. Proposed Rule Overview
• Goal: Create regulations that are a better fit
for the healthcare industry
• Provide regulatory clarity and national
consistency
• Includes 3 major components:
1. Nicotine Amendment
2. Sewering Ban
3. Subpart P
14

15. Nicotine Amendment
• FDA-approved over-the-counter
nicotine replacement therapies
will no longer meet the P075
listing
• Includes
▪ Patches
▪ Gums
▪ Lozenges
• These are now non-hazardous
15

16. Nicotine Amendment
• Other types of nicotine are still a
listed, acute hazardous waste
• This includes:
▪ E-liquids for use in e-cigarettes,
cartridges, etc.
▪ Prescription nicotine (e.g., nasal
spray)
▪ Other chemical formulations, such
as research material and
pesticides
16

17. Sewering Prohibition
• No hazardous waste
pharmaceuticals can be sewered
(drain-disposed into a sewer)
17

18. Where Do The Regulations Live?
• 40 CFR Part 266 – Standards for the management of specific
hazardous wastes and specific types of hazardous waste
management facilities
• Part 266 Subpart P – Management standards for Hazardous
Waste Pharmaceuticals
18

19. 40 CFR Part 266 Subpart P
• “Subpart P” is listing of new regulations specific to hazardous
waste pharmaceuticals generated in healthcare facilities (waste-
specific and sector-specific)
• Includes new definitions and new management standards
19

20. Agenda
20
Background
Definitions
Management Standards
Generator Programs
Q&A

21. “Pharmaceutical”
1. Any drug or dietary supplement
for use by humans or other
animals
2. Any electronic nicotine delivery
system (ENDS)
3. Any liquid nicotine/e-liquid
packaged for retail sale for use
in ENDS
• Does NOT include:
▪ Dental amalgam
▪ Sharps
▪ Medical waste
21

22. “Hazardous Waste
Pharmaceutical”
• A pharmaceutical that is a solid
waste is a hazardous waste
pharmaceutical if it:
▪ Exhibits a HW characteristic (D-list)
▪ Is a listed HW (P, K, U, F-lists)
• Other than the nicotine
amendment, no other criteria
has changed
• Subpart P applies only to HWPs,
material that was previously
regulated
22

23. Reverse Logistics vs. Reverse
Distribution
23
Reverse Logistics Reverse Distribution
Has to do with non-Rx pharmaceuticals (OTCs,
supplements, homeopathic) and retail items
Has to do with Rx pharmaceuticals
Potential to be re-sold and reused in secondary
markets
Potential to for healthcare facilities to be credited
by manufacturer
NOT a solid waste per RCRA if there is a
reasonable expectation for re-use, therefore NOT
a hazardous waste pharmaceutical
This material is a solid waste, and therefore a
hazardous waste pharmaceutical

24. 3 Types of “Hazardous Waste
Pharmaceuticals”
1. Non-creditable hazardous waste pharmaceuticals
- Will not receive manufacturer credit
2. Potentially creditable hazardous waste pharmaceuticals
- May receive manufacturer credit
3. Evaluated hazardous waste pharmaceuticals
- It has been determined by a reverse distributor whether manufacturer
credit will be received or not
- Will not often apply to healthcare facility generators
24

25. Non-Creditable “Hazardous Waste
Pharmaceuticals”
• Broken or leaking
• Repackaged
• Dispensed
• Expired >1 year
• Investigational new drugs
• Contaminated PPE
• Floor sweepings
• Clean-up material
25

26. Potentially Creditable “Hazardous
Waste Pharmaceuticals”
• Original manufacturer packaging
(except recalls)
• Undispensed
• Unexpired or less than 1-year past
expiration
26

27. Evaluated “Hazardous Waste
Pharmaceuticals”
• At the reverse distributor,
manufacturer’s credit will be
determined/verified
• Following this, the “evaluated”
HWP is transported from the
reverse distributor to a
Hazardous Waste Treatment,
Storage, or Disposal Facility
(TSDF)
27

28. 28

29. New Definition of Empty
• FOR BOTH ACUTE AND NON-ACUTE:
1. Stock/Dispensing Bottles (1 liter or 10,000 pills) & Unit-dose
containers
→ empty when contents are removed
2. Syringes
→ empty when plunger is fully depressed
3. IV Bags
→ empty when contents are fully administered
29

30. New Definition of Empty
• FOR “OTHER CONTAINERS” (not listed in #1-3 above)
1. Non-Acute: Normal definition of “RCRA Empty” per 261.7(b)
2. Acute: Cannot be “RCRA Empty”
30

31. Agenda
31
Background
Definitions
Management Standards
Generator Programs
Q&A

32. Important Dates
• Published in the Federal Register on February 21st, 2019
• Effective 6 months later--August 21st, 2019 in:
▪ Non-authorized states (Iowa, Alaska)
▪ Indian Country
▪ US Territories (except Guam)
• Nicotine Amendment – LESS stringent
▪ Authorized states have no requirement or deadline to adopt
• Sewer Prohibition
▪ Goes into effect immediately (August 21st, 2019) in all states
• Subpart P – MORE stringent
▪ Authorized states must adopt by July 1st, 2021
▪ Authorized states that require a statutory amendment must adopt by July 1st, 2022
32

33. What is a Healthcare Facility?
“Lawfully authorized” to:
1. Provide healthcare
2. Distribute, sell, or dispense pharmaceuticals
33
Examples:
• Wholesale distributors
• Hospitals
• Physician’s Offices
• Long-term care facilities
• Veterinary clinics
• Pharmacies
Does NOT include:
• Pharmaceutical
manufacturers
• Reverse distributors

34. Does Subpart P Apply to Your
Healthcare Facility?
First question to ask…
What is your generator status,
counting ALL the types of hazardous
waste generated?
1. If you are a VSQG, you are not
required to follow Subpart P, although
you can opt in
2. If you are an SQG or LQG, you MUST
comply with Subpart P
34

35. One-Time Notification
• Must notify via Site ID form (8700-12):
▪ Either 60 days following effective date, or
▪ During next biennial report cycle if your facility is required to
report
35

36. Waste Tracking
• There are no generator
categories having to do with
HWP
• HWP quantities do not have to
be tracked or reported on
biennial report
36

37. Training Requirements
• All personnel managing non-creditable
hazardous waste pharmaceuticals must
be thoroughly familiar with proper waste
handling and emergency procedures
relevant to their responsibilities during
normal facility operations and
emergencies
• (Similar to RCRA SQG training
requirements)
37

38. Container Standards: Non-Creditable HWP
• Labeling
▪ Must have the words “Hazardous
Waste Pharmaceuticals”
• Containers
▪ Structurally sound, compatible with
contents
▪ Closed and secure from
unauthorized access
• Accumulation Time
▪ Up to 1 year onsite
38

39. Container Standards: Non-Creditable HWP
• There are no longer satellite
accumulation areas (SAAs) and central
accumulation areas (CAA) for
hazardous waste pharmaceuticals (as
defined by the regulations)
• Therefore, the concepts of “collection
at or near the point of generation”,
transferring waste to CAA within 3
days, inspection logs, etc. are not
included in this rule
• (Think: Universal Waste rule)
39

40. Offsite Shipments Non-Creditable HWP
1. Uniform hazardous waste
manifest and HW transporter
are still required
2. The code “PHARMS” is used
on the manifest in lieu of
hazardous waste codes
3. Must be sent to a Hazardous
Waste Treatment, Storage, and
Disposal Facility (TSDF)
40

41. Container Standards: Potentially
Creditable HWP
• No labeling, container
standards, or accumulation time
limits
41

42. Offsite Shipments Potentially
Creditable HWP
1. Manifest and HW transporter
are NOT required—common
carrier is acceptable.
2. Shipper must receive delivery
confirmation from reverse
distributor—electronic tracking
is acceptable.
42

43. HWP That Are Also Controlled
Substances
• There are multiple hazardous
waste pharmaceuticals that also
meet the criteria of a Drug
Enforcement Agency (DEA)
Controlled Substance
• These include chloral hydrate
and multiple other substances
that may be dissolved in a
flammable alcohol solution
43

44. HWP That Are Also Controlled
Substances
• These materials are EXEMPT from
RCRA, provided:
1. The material is not sewered
2. It is managed in compliance with DEA
regulations
3. It is destroyed by:
▪ a method that the DEA has publicly deemed in
writing to meet their non-retrievable
standards, or
▪ incinerated at a municipal waste combustor,
infectious waste incinerator, solid waste
incinerator, or hazardous waste combustor.
44

45. Agenda
45
Background
Definitions
Management Standards
Generator Programs
Q&A

46. Accumulation
• Old: SAA containers are located at or
near the point of generation, and can
accumulate waste without a time limit
until in excess of 55-gallons. From the
SAA, the container must be transported
directly to the CAA.
• New: HWP containers are not required
to be at or near the point of generation;
however, waste may only accumulate for
a maximum of one year, regardless of
location.
46

47. Acute vs. Non-Acute
• Old: Certain healthcare facilities collect
acute wastes separately from non-acute
waste streams. Adding P-codes to the
primary waste stream often puts VSQGs
into the LQG category.
• New: There are no generator statuses
under Subpart P. There is no longer a
reason to segregate acute from non-
acute.
47

48. Hazardous vs. Non-Hazardous
• Old: Certain healthcare facilities collect only the
pharmaceuticals that meet the criteria for
hazardous waste, communicating this information
via training and signage (generally 20-40
medications). Non-hazardous pharmaceuticals are
sewered or placed in other waste streams to avoid
placing the facility into a higher generator category.
• New: There are no generator statuses and
healthcare facilities are encouraged to commingle
hazardous and non-hazardous. Training on PC vs.
NC vs. empty may be more intuitive and reliable
than relying on frontline staff to make hazardous
waste determinations.
48

49. Agenda
49
Background
Definitions
Management Standards
Generator Programs
Q&A

50. Summary
• Subpart P will ultimately ensure that hazardous waste
regulations are more easily complied with by healthcare
facilities
• State-by-state adoption plans and timelines are critical to
understand
• You need to understand how your program currently operates
before you know what needs to change (there still may be a few
years of inspections under the old rule)
50

51. Questions?