a new role for consultant pharmacists EPA

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2021 Annual Meeting & ExhibitionNovember 4-7, 2021 | San Diego, California

A New Role for Consultant Pharmacists

EPA’s New Pharmaceutical Waste RuleNovember 5, 2021

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Meet the Speaker

Charlotte Smith is Senior Regulatory Advisor, PharmEcology Services, a business unit of WM Sustainability Services and President of GreatWorks LLC. She founded PharmEcology Associates, LLC in 2000 and sold the company to Waste Management in 2009. She co-founded Capital Returns, Inc., a nationally recognized pharmaceutical reverse distributor in 1991 and for 10 years served as president and chief regulatory advisor. Ms. Smith is a registered pharmacist who received her BS in Pharmacy and MS in Continuing and Adult Vocational Education from the University of Wisconsin. She is a member of the Pharmacy Society of Wisconsin, the American Society of Health-System Pharmacists, and the American Society of Consultant Pharmacists.

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Disclosure

I am a consultant for PharmEcology Services, WMSS.Legal Disclaimer: This information is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information.

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Learning Objectives

1. Apply EPA’s new Hazardous Waste Pharmaceuticals Rule, also known as Subpart P, to their practice setting, be it in a pharmacy or at a long-term care facility.

2. Assess pharmaceutical waste practices at their clients’ facilities and make recommendations to assure compliance with EPA and DEA.

3. Apply the parameters of hazardous waste generator status to their pharmacies or long-term care clients.

4. Demonstrate the ability to complete the required or recommended EPA 8700-12 registration form for their pharmacies or long-term care clients.

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A Quick Review of the Hazardous Landscape

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Defining Hazardous

• EPA Hazardous Waste: meets one of the definitions of hazardous waste federally or at the state level: P- or U-listed, characteristic of toxicity, ignitability, corrosivity, reactivity; must be a waste vs. a product• OSHA Hazardous Drug: a risk to employees due to occupational exposure;

may be a product or a waste• NIOSH 2016 Hazardous Drug List*/USP 800 (NIOSH 2020 Draft List

published but not finalized)• DOT Hazardous Material: a risk to health and safety while in transit; may be

a product or a waste• Biohazardous: meets the definition of an infectious risk at the state level;

may be a product or a waste

*https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

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https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

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Hazardous Drugs vs Hazardous Waste

©2021 WM National Services, Inc.

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Quick Review of HWPs Under RCRA

• P-listed pharmaceuticals (acutely hazardous)• Sole active ingredient; unused; empty containers (prior to Subpart P)• Examples: nicotine, warfarin

• U-listed pharmaceuticals (toxic)• Sole active ingredient; unused• Examples: cyclophosphamide, mitomycin, lindane, selenium sulfide

• Pharmaceuticals that exhibit a characteristic of hazardous waste (D codes)• Ignitability D001, Toxicity D004 – D043 • Corrosivity D002, Reactivity D003

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Examples of Common P-Listed Drugs

•Warfarin unit-dose or stock bottles

•Over-the-counter nicotine replacement therapy gum, lozenge, or patch (excluded under new rules)

• Prescription nicotine replacement therapy may be an inhaler or a spray

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Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity• Preservatives: thimerosal & m-cresol

• Nutritions containing chromium and/or selenium depending on concentration, e.g. Centrum Silver

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Characteristics of Ignitability

• Aqueous solution containing 24% alcohol or more by volume and flash point <140 F°• Rubbing alcohol, hand sanitizers• Topical preparations: e.g. testosterone gel CIII• Injections: e.g. diazepam vials CIV• Oral preparations: Subsys (fentanyl )CII, paregoric CIV

• Non-aqueous solutions with flash points <140 F°• Oxidizers: e.g. silver nitrate sticks (unused) • Flammable aerosols e.g. Kenalog® aerosol spray• Hazardous waste code D001

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How is Pharmaceutical Waste Managed in Healthcare?

Biohazardouspharmaceutical waste, needles, and other sharps

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Quick Check

Which of the following drugs are both hazardous drugs on the NIOSH list 2016 and hazardous waste under EPA regulations? More than one may be correct. A. MethotrexateB. WarfarinC. CyclophosphamideD. Centrum Silver

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40 CFR 266 Subpart P: Hazardous Waste Pharmaceuticals (HWPs)

• It is only the second time in the history of RCRA that EPA has carved out an industry-specific regulation. The first time was for academic labs in 2008.

• Due to the very different nature of healthcare, EPA has created a specific section to address healthcare facilities and reverse distributors.

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Healthcare Facility Definitions• Very broad definition (List not all inclusive)

• Wholesale distributors (of drugs)• Third-party logistics providers• Hospitals• Ambulatory surgery centers• Physicians’ offices• Long term care facilities• Pharmacies

• NOT INCLUDED in healthcare definition: • Reverse distributors – separate regulations within Subpart P• Pharmaceutical manufacturers – current hazardous waste regulations • Reverse logistics centers – current hazardous waste regulations

40 CFR 266.502 Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals. https://www.ecfr.gov/cgi-bin/text-idx?node=sp40.29.266.p&rgn=div6#se40.29.266_1502

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EPA’s Definition of Long-Term Care Facility40 CFR 266.500• A licensed entity that provides assistance with activities of daily living• Includes: hospice facilities, nursing facilities, skilled nursing facilities • Does NOT include: group homes, independent living communities, assisted

living facilities

40 CFR 266.502 Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals.https://www.ecfr.gov/cgi-bin/text-idx?node=sp40.29.266.p&rgn=div6#se40.29.266_1502

40 CFR 266.503 Standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals. https://www.ecfr.gov/cgi-bin/text-idx?node=sp40.29.266.p&rgn=div6#se40.29.266_1503;

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https://www.ecfr.gov/cgi-bin/text-idx?node=sp40.29.266.p&rgn=div6



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Who Does the Subpart P Rule Apply To?

• Healthcare facilities, including retail and LTC provider pharmacies, that are large quantity (LQG) or small quantity (SQG) hazardous waste generators, including long term care facilities that meet these criteria

• Very small quantity generators (VSQG, fka Conditionally Exempt Small Quantity Generator) may participate but are not obligated to

• A long-term care facility with 20 beds or fewer is presumed to be a VSQG and only subject to the sewer prohibition

• Reverse distributors who manage outdated drugs for credit

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EPA’s Hazardous Waste Pharmaceutical Initiatives

• EPA banned drain disposal of hazardous waste pharmaceuticals (HWPs)•August 21, 2019 nationwide

• EPA has also removed OTC nicotine gums, lozenges, and patches from the P-list of hazardous waste under 40 CFR 261.33(e)•August 21, 2019 federally (Iowa, Alaska)

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EPA’s Hazardous Waste Pharmaceutical Initiatives cont.• 40 CFR Subpart P: EPA has added an entirely new section to the

hazardous waste regulations considered to be stricter than the current regulations, therefore states must adopt it into their programs• 40 CFR Subpart P Hazardous Waste Pharmaceuticals• August 21, 2019 federally (Iowa, Alaska)• Other states adopting up until July 1, 2022 depending

upon if they can do so through regulation or legislation• Hazardous waste controlled substances exempted under

specific conditions

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Which States Have Adopted Subpart P? • AK, IA, PR, VI, Indian Country, US Territories except Guam;

AL, AZ, CO, DE, FL, GA, HI, ID, IL, IN, KY, NC, ND, NJ, OH, OK, PA, SC, UT, VA, SD, WA, WI, WV

• NH, CA and MD adopted only the OTC Nicotine exclusion while NY will use enforcement discretion to exclude nicotine

• MN has informally adopted the nicotine exclusion and some of the aspects of the new rule.

• Designations on map are updated as of July 6, 2021 and listed states are updated as of July 6, 2021

https://www.epa.gov/hwgenerators/where-are-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075

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Sewer Prohibition for all Hazardous Waste Pharmaceuticals• Sewering of HWPs is PROHIBITED nationally• All healthcare facilities • Pharmaceutical Reverse Distributors

• Includes hazardous waste controlled substances

• HSWA Provision (Hazardous and Solid Waste Amendments, 1984): effective in all states August 21, 2019

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How Should Provider Pharmacies and LTCFs Comply with the EPA HWP Sewering Prohibition?• Does the provider pharmacy stock ANY hazardous waste

pharmaceuticals that are controlled substances?• Are any of the attending physicians routinely writing for CS that become

hazardous waste if disposed? • SHOULD NOT place un-sequestered CS wastage in any waste containers,

including red sharps! Too much opportunity for diversion throughout the storage, transport and disposal sequence of activities

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Hazardous Waste Generator Status Definitions

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Will HWPs Still Count Towards Generator Status under Subpart P?• No, this is one of the major benefits of the new rule. They only need

to be counted initially to determine if the facility must comply with Subpart P. • If the initial determination meets the LQG or SQG quantity

requirements, the organization must participate in 40 CFR 266 Subpart P.

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Will HWPs Still Count Towards Generator Status under Subpart P? (cont.)• All HWPs are managed the same• No tracking of monthly generated amounts of HWPs• No separation of P-listed HWPs• Decreases episodic generation possibilities • No longer a disincentive to manage all pharmaceutical waste as

HWPs• Total accumulation time of ONE YEAR: recommend dating when

first used

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What Are the Container Labeling Requirements Under Subpart P?

• Accumulation containers must be individually labeled• No hazardous waste codes or other labeling required• Containers must be sturdy, non-reactive, and kept closed (not

sealed) when not in active use• Containers must be secured to prevent unauthorized access• Total accumulation time: one year

Hazardous Waste Pharmaceuticals

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OTC Nicotine Gums, Lozenges, and Patches Removed from the P-list of Hazardous Waste Federally• 261.33(e) will exempt OTC nicotine lozenges, gums, and patches,

which includes the packaging.

• Unused nicotine lozenges, gums, and patches should be managed as nonhazardous pharmaceutical waste as a Best Management Practice.

• NOTE: Rx Nicotine drug/packaging is NOT EXEMPT

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Empty Containers Exempted for Most HWPs

Stock bottle, dispensing bottle, vial, or ampule not to exceed 1 liter or 10,000 pills or a unit-dose container or delivery device is empty when drugs have been removed using practices commonly employed for that type of container

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Management of Residues in Syringes

• Syringes• Empty when contents have been removed by fully depressing the plunger• If not empty and has a needle attached, must be managed as “dual”

hazardous/biohazardous waste

• Three methods for becoming “empty”• Administration to patient• Injecting contents into an IV or other delivery system• Emptying remaining contents into a hazardous waste collection container

• Absorbent/adsorbent material recommended to avoid free liquids

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Management of Residues: IV Bags

• The container is “RCRA empty” if:• U-listed or characteristic hazardous waste – fully administer the contents or

no more than 3% by weight remains• P-listed – fully administer the contents. No triple rinsing allowed or required.

• e.g. a fully used IV bag of arsenic trioxide can be disposed as trace chemotherapy (yellow) rather than as a hazardous waste (black)

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Management of Residues: Inhalers, Aerosols, Nebulizers, Ointments, Gels, Creams• Pharmaceuticals that have been fully administered to a patient and

are NOT P-listed are RCRA empty• If not fully administered and NOT P-listed:

• All wastes have been removed that can be removed using the practices commonly employed to remove materials from that type of container, AND

• No more than 3% by weight of the total capacity of the container remains in the container

• If not fully administered AND P-listed HWP, must be managed as a HWP

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Quick Check

Which of the following statements are true under the new hazardous waste pharmaceutical rule? More than one may be correct. A. An empty warfarin blisterpak will no longer be a hazardous waste when a state adopts the new rule. B. All nicotine in finished dosage forms is exempt federally from P075 and therefore not a hazardous waste when discarded.C. All controlled substances can continue to be disposed down the drain to prevent diversion.

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EPA Conditions of the Controlled Substance Hazardous Waste Exemption• Controlled substances that are also a hazardous waste will be

exempted from the RCRA hazardous waste regulations under Subpart P, assuming all DEA requirements for disposal are met.

• No hazardous waste controlled substances can be sewered

• Must be destroyed by a method DEA has publicly deemed in writing to meet non-retrievable standard, OR…

• Must be incinerated by 1 of 5 types of permitted incinerators

https://www.govregs.com/regulations/expand/title40_chapterIi28_part266_subpartP_section266.507#regulation_6

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Operational Impact of DEA Exemption

• Disposal of controlled substance “wastage” in long term care facilities should include sequestration into a device that renders the drugs “non-divertable”

• Devices where hazardous waste controlled substances were added will no longer need to be disposed in a hazardous pharmaceutical waste container, but can be disposed as non-hazardous pharmaceutical waste when managed through incineration

• Can be managed in an on-site kiosk if available• Cannot be disposed in the trash

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Examples of Controlled Substance Sequestration Systems

Rx Destroyer™RxCarbon™ Pad

Cactus Smart Sink® Cs RX®

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PRIOR to Subpart P - Controlled Substance Decision Tree

Pharmacy Inventory

Outdated CS(All Dosage Forms)

Non-Hazardous

Waste Incinerator

Hazardous Waste

Incinerator

Non-Hazardous

Waste Incinerator

Two Employees Witness, Form 41, Non-Haz

Only

Reverse Distributor

Unused CS

In LTCF

Sequestration

Device (e.g., Cactus, Rx Destroyer)

Hazardous

Waste Receptacle

Non-Hazardous

Waste

Receptacle

Witnessed wastage

Hazardous Waste/Non-Haz in Cartridge

Non-Hazardous Waste in Cartridge

Non-Hazardous

Waste Vendor

Drain Disposal

_ _ _

Hazardous Waste Vendor

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Revised Controlled Substance Decision Tree Under Subpart P: Pharmacy Inventory

Pharmacy Inventory

Outdated CS

(All Dosage Forms)

Non-Hazardous

Waste Incinerator

Non-Hazardous

Waste Incinerator

Two Employees Witness, Form 41,

All CS

Reverse Distributor

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Revised Federal Controlled Substance Decision Tree Under Subpart P (Haz Waste) Alternatives

Unused CS

on Nursing Unit

Sequestration Device (e.g., Cactus, Rx Destroyer)

Non-Hazardous

Pharm Waste

Receptacle

Witnessed wastage

Exempt CS Non-Hazardous

Waste

Non-Hazardous

Waste Vendor

DEA Consumer Kiosk

Provider Pharmacy Management

Reverse Distributor

No Drain Disposal

Be sure to check state regulations to ensurethe controlled substance exemption is adopted.

Discontinued residents’ meds

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DEA Q and AQuestion: May a Long-Term Care Facility (LTCF) dispose of controlled substances on behalf of an LTCF resident or decedent?

Answer: Yes. An LTCF may dispose of controlled substances in schedules II-V on behalf of a resident or decedent of the facility who is or was in lawful possession of that controlled substance.21 CFR 1317.30(b)(3). The controlled substances must be disposed of by transferring them into an authorized collection receptacle located at that LTCF within three business days after the permanent discontinuation of use as directed by the prescriber, or the resident’s transfer from that facility, or as a result of death. 21 CFR 1317.80. An LTCF must also ensure disposal is done in accordance with all applicable State, tribal and local controlled substance disposal laws and regulations.EO-DEA174, October 5, 2020

https://www.deadiversion.usdoj.gov/faq/disp_destr_faq.htm

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(a) LTCF may dispose of a controlled substance on behalf of an ultimate user by transferring into a receptacle within 3 days of the order being discontinued (b) Only authorized retail or hospital pharmacies may “supervise the removal, sealing, transfer, and storage of sealed inner liners”(c) The installation, removal, transfer, and storage of inner liners shall be performed either: By or under the supervision of one employee of the authorized collector and one supervisor-level employee of the long-term care facility (e.g., a charge nurse or supervisor) etc.(d) sealed inner liners may only be stored at the long-term care facility for up to three business days

§1317.80 Collection Receptacles at Long-term Care Facilities.

https://www.deadiversion.usdoj.gov/21cfr/cfr/1317/subpart_b.htm#80

https://apps.deadiversion.usdoj.gov/webforms2/spring/disposalLogin?execution=e1s1

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https://www.deadiversion.usdoj.gov/21cfr/cfr/1317/subpart_b.htm

https://www.deadiversion.usdoj.gov/21cfr/cfr/1317/subpart_b.htm

https://apps.deadiversion.usdoj.gov/webforms2/spring/disposalLogin?execution=e1s1

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Placement of Collection Receptacles

• 1317.75 Collection receptacles (d)(2)(iii) At a long-term care facility: A collection receptacle shall be located in a secured area regularly monitored by long-term care facility employees.

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Challenges in Implementing DEA & Subpart P Options• Pharmacy employee must be present to change out inner liners • Provider pharmacy must also set up reverse distributor relationship• Not all LTCFs have pharmaceutical waste vendor relationships• Difficulty in identifying hazardous waste pharmaceuticals in a

dynamic setting

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Identification and Management of Hazardous Waste Pharmaceuticals: Summary• Provider pharmacy can access information through a review of

inventory by various consulting groups • Provider pharmacy can identify hazardous waste pharmaceuticals on

dispensed packaging• For non-Subpart P states, P-listed very important, including warfarin &

nicotine• For Subpart P states, no longer needed

• Provider pharmacy and/or consultant pharmacist can provide training on pharmaceutical waste management• Consulting groups can provide guidance in determining an optimal

solution based on the state regulations and vendor availability

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Change in Outdated Drug Management at the Provider Pharmacy• Outdated drugs now considered waste at the facility when they

outdate• Segregate outdates immediately into potentially creditable (returns)

and waste• Segregate waste into hazardous and non-hazardous or all hazardous• DO NOT wait for your returns company to do the segregation

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Definition of “Potentially Creditable”

• Undispensed• In the original manufacturer’s package• Unexpired or less than 1 year past expiration date• Reverse distributors MUST REPORT receipt of noncompliant

waste• Non-creditable HWPs including drugs returned from LTCFs• Non-pharmaceutical hazardous waste• Regulated medical waste (biohazardous)

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Quick Check

Which of the following outdated drugs can be sent to a reverse distributor under the new pharmaceutical waste regulation?

A. Outdated warfarin repackaged into unit dose punch cards by the pharmacy

B. Outdated Centrum Silver® in the original stock bottle

C. Nicotrol® Nasal Spray labeled for patient use and returned to the pharmacy

D. None of the above

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Which Facilities Need to Register Under Subpart P?

• All current large and small quantity generators of hazardous waste• Must submit or amend EPA Form 8700-12 Identification Form• Very Small Quantity generators may register but are not required to

do so• Determine provider pharmacy generator status• Determine generator status of long-term care facilities

https://www.pharmecology.com/News/Details/52

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Key Takeaways

• No hazardous waste drugs can be sewered• OTC Nicotine gums, lozenges, and patches are exempt from

hazardous waste regulations• The definitions of “empty” have changed significantly in your favor• Send only potentially creditable outdated HWPs to your reverse

distributor• All LQGs and SQGs must register under subpart P when your state

adopts the regulation

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Summary• The new hazardous waste pharmaceutical rules have a lot of moving

parts• Sewer prohibition• OTC Nicotine exclusion• P-listed packaging exclusion• DEA hazardous waste exclusion• Registration requirement

• Taking the time to work through these changes can save your facility time, money, and violations• Applying these changes to your consultant practice settings can

provide a “value add” to your services

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References • Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine website.

https://www.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals

• NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 website. https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

• Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information website. https://www.cdc.gov/niosh/docket/review/docket233c/default.html

• 40 CFR 266.500. Definitions of Hazardous Waste Pharmaceuticals. https://www.ecfr.gov/cgi-bin/text-idx?node=sp40.29.266.p&rgn=div6#se40.29.266_1500

• 40 CFR 266.502 Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals. https://www.ecfr.gov/cgi-bin/text-idx?node=sp40.29.266.p&rgn=div6#se40.29.266_1502

• 40 CFR §261.33 Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof. https://www.ecfr.gov/cgi-bin/text-idx?node=pt40.28.261&rgn=div5#se40.28.261_133

• 40 CFR 266.507 Residues of hazardous waste pharmaceuticals in empty containers. https://www.ecfr.gov/current/title-40/chapter-I/subchapter-I/part-266#266.507

• 40 CFR § 271.21 Procedures for revisions of State programs. https://www.ecfr.gov/cgi-bin/text-idx?SID=bc22a4c6cb21f646f8d50f2768827ccb&node=pt40.27.271&rgn=div5#se40.29.271_121

• Drug Disposal Information, U.S. Dept. of Justice, Drug Enforcement Administration, Diversion Control Division website. https://www.deadiversion.usdoj.gov/drug_disposal/index.html

• Disposal and Destruction Q and A, U.S. Dept. of Justice, Drug Enforcement Administration, Diversion Control Division website.https://www.deadiversion.usdoj.gov/faq/disp_destr_faq.htm

• Registering under Subpart P: https://www.pharmecology.com/News/Details/52

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https://www.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals

https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

https://www.cdc.gov/niosh/docket/review/docket233c/default.html



https://www.ecfr.gov/cgi-bin/text-idx?SID=bc22a4c6cb21f646f8d50f2768827ccb&node=pt40.27.271&rgn=div5

https://www.deadiversion.usdoj.gov/drug_disposal/index.html

https://www.deadiversion.usdoj.gov/faq/disp_destr_faq.htm

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Questions or Need Assistance?

Charlotte Smith, R. Ph., M.S.Senior Regulatory Advisor

[email protected]

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mailto:[email protected]

a new role for consultant pharmacists EPA

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