PHEDERAL PHARMACEUTICAL ALPHABET SOUP The 5th National Product Stewardship Forum and the 2009 Northwest Hazardous Materials Conference for Household and Small Business Programs Hyatt Olive 8 Hotel ~ Seattle, WA June 1-4, 2009 Presented By: David Stitzhal Northwest Product Stewardship Council & Full Circle Environmental, Inc. Federal Touchstones for State Medicine Return Policy DOT EPA DOJ FDA USPS ONDCP CSA

Overview There is a lot going on federally that interacts with state policy development and program design for management of unwanted medications.

Overview There is a lot going on federally that interacts with state policy development and program design for management of unwanted medications. Pharmaceuticals -- more than most products at end-of-life -- are regulated, or otherwise overseen, by several federal agencies and statutes.

Overview There is a lot going on federally that interacts with state policy development and program design for management of unwanted medications. Pharmaceuticals -- more than most products at end-of-life -- are regulated or otherwise overseen by several federal agencies and statutes. This presentation provides a snapshot of issues from a handful of federal agencies.

Overview There is a lot going on federally that interacts with state policy development and program design for management of unwanted medications. Pharmaceuticals -- more than most products at end-of-life -- are regulated or otherwise overseen by several federal agencies and statutes. This presentation provides a snapshot of issues from a handful of federal agencies. Some substantial progress has already been made against seemingly intractable obstacles.

DEPARTMENT OF TRANSPORTATION – Once you have collected unwanted medications through a take-back program, you have to ship them for disposal.

More specifically…… Household hazardous waste that is pharmaceutical waste should be shipped under: – Medicine, solid/ liquid, toxic, n.o.s. (not otherwise specified), division 6.1 or Consumer Commodity ORM-D (if in the original consumer package) defined in 49 CFR ORM-D includes medications. The volume limit for ORM-D is 66 lbs. – Unpackaged medicine, solid/liquid, toxic, n.o.s. had a shipping limit of 11 lbs (solid).

Progress: – For mixed pills that had been taken out of their consumer packaging (loose pills) the PH:ARM take-back program in Washington was using the DOT designation of “Medicine, Solid, Toxic, Not Otherwise Specified”.

Progress: – For mixed pills that had been taken out of their consumer packaging (loose pills) the PH:ARM take-back program in Washington was using the DOT designation of “Medicine, Solid, Toxic, Not Otherwise Specified”. – Materials shipped under this designation had been limited to 11 lbs (about 1/3 of a 5 gallon bucket).

Progress: – For mixed pills that had been taken out of their consumer packaging (loose pills) the PH:ARM take-back program in Washington was using the DOT designation of “Medicine, Solid, Toxic, Not Otherwise Specified”. – Materials shipped under this designation had been limited to 11 lbs (about 1/3 of a 5 gallon bucket). – DOT has removed that special provision from 3 medicine shipping names. The 11 pound limit no longer applies. (We changed a federal reg.!)

Drug Enforcement Administration The Primary Roadblock: Drugs specified by the Controlled Substances Act can not currently be accepted by anyone other than the DEA or law enforcement officials.

Drug Enforcement Administration The public doesn’t know which drugs are controlled substances. The Primary Roadblock: Drugs specified by the Controlled Substances Act can not currently be accepted by anyone other than the DEA or law enforcement officials.

Drug Enforcement Administration The public doesn’t know which drugs are controlled substances. There are challenges with arranging for law enforcement presence, and they arguably should not be spending their time collecting used medication. The Primary Roadblock: Drugs specified by the Controlled Substances Act can not currently be accepted by anyone other than the DEA or law enforcement officials.

Drug Enforcement Administration The public doesn’t know which drugs are controlled substances. There are challenges with arranging for law enforcement presence, and they arguably should not be spending their time collecting used medication. It is inefficient and impractical to collect controlled’s and other medication separately. The Primary Roadblock: Drugs specified by the Controlled Substances Act can not currently be accepted by anyone other than the DEA or law enforcement officials.

Change on the Horizon The DEA – through an Advance Notice of Proposed Rulemaking (ANPRM) issued January 21, has solicited opinions and responses to a set of questions for input on managing unwanted medications. The PSI Regulatory Workgroup (under the National Pharmaceuticals Dialogue) helped organize joint and individual agency comments to the ANPRM. REMINDER: There are limited legal options for collecting controlled substances from the public. Law enforcement presence at collection sites. Mail-back to authorized law enforcement receiver, such as the DEA program in Maine.

Proposed Inslee Bill Representative Inslee (D-WA) [with Representative Moran (D-VA)] introduced a bill to establish the Safe Drug Disposal Act of 2009.InsleeMoran Purpose: “To amend the Controlled Substances Act to provide for disposal of controlled substances by ultimate users and care takers through State take-back disposal programs,” “to amend the Federal Food, Drug, and Cosmetic Act to prohibit recommendations on drug labels for disposal by flushing…” Referred to two Subcommittees: Energy & Commerce and Judiciary. No hearings currently scheduled.

Safe Drug Disposal Act of 2009 H.R (proposed) 2/25/2009--Introduced. Amends the Controlled Substances Act: (1) authorizes an ultimate user or care taker to dispose of a controlled substance in accordance with a prescribed state program; (2) includes five model state programs providing for such disposal through delivery to a designated facility; and (3) allows a state to work with the Attorney General to devise an alternative disposal program that is consistent with this Act.

Safe Drug Disposal Act 2009 (continued) Requires each such program to: (1) enact state legislation as a prerequisite to its adoption and implementation;

Safe Drug Disposal Act 2009 (continued) Requires each such program to: (1) require a state to enact legislation as a prerequisite to its adoption and implementation; (2) protect the public safety; (3) allow disposal of controlled substances through persons other than law enforcement personnel; (4) incorporate environmentally sound practices for disposal; (“by means other than flushing down a public or private wastewater treatment system or disposing in a municipal solid waste landfill”)

Safe Drug Disposal Act 2009 (continued) Requires each such program to: (1) require a state to enact legislation as a prerequisite to its adoption and implementation; (2) protect the public safety; (3) allow disposal of controlled substances through persons other than law enforcement personnel; (4) incorporate environmentally sound practices for disposal; (“by means other than flushing down a public or private wastewater treatment system or disposing in a municipal solid waste landfill”) (5) be cost-effective; (6) include convenient take-back options for urban and rural locations; and (7) not restrict the funding a state may use to implement it.

Food & Drug Administration FDA worked with the White House Office of National Drug Control Policy (ONDCP) to develop consumer guidance for proper disposal of prescription drugs. tml tml There is no requirement that disposal information be included or excluded in the labeling.

Current FDA Guidance: Flush these: Actiq (fentanyl citrate), Daytrana Transdermal Patch (methylphenidate), Duragesic Transdermal System (fentanyl), OxyContin Tablets (oxycodone), Avinza Capsules (morphine sulfate), Baraclude Tablets (entecavir) Reyataz Capsules (atazanavir sulfate), Tequin Tablets (gatifloxacin), Zerit for Oral Solution (stavudine), Meperidine HCl Tablets, Percocet (Oxycodone and Acetaminophen), Xyrem (Sodium Oxybate), Fentora (fentanyl buccal tablet) Flush-recommended drugs are mostly controlled substances. FDA is concerned about diversion.

Recent Triumphs Through work growing out of the PSI National Dialogue, the FDA changed the priority order of their recommendations for drug disposal. 1)Don’t flush (except for the listed drugs) 2)Use take-back programs 3)Adulterate 4)Seal and dispose

A Sample of Remaining Issues Fentanyl patches (on the flush list) are a problem for wastewater treatment plants and on-site septic systems. Many groups are advocating for a no-flush policy for all medications.

EPA, THE UNIVERSAL WASTE RULE and RCRA What is the Universal Waste Rule? The universal waste rule (UWR) streamlines hazardous waste management standards for certain designated hazardous wastes, which are referred to as universal wastes (UW).

27 Why have a Universal Waste Rule? A universal waste is still a hazardous waste, but the generator requirements are simplified in order to: Promote the collection of these wastes; Promote the proper recycling, treatment or disposal of these wastes; and Reduce the burden on businesses.

What Are the Current Federal Universal Wastes? Batteries, pesticides, mercury-containing equipment (MCEs), and lamps

What Are the Current Federal Universal Wastes? Batteries, pesticides, mercury-containing equipment (MCEs), and lamps Why are these wastes special?  Compared to other hazardous wastes, these wastes are relatively low-risk during accumulation and transport.  They are frequently generated in a wide variety of settings.  They are generated by a vast community  Present in significant volumes in non-hazardous waste management systems (e.g., household trash).

30 So what about unwanted medicines and the Universal Waste Rule? To answer this we have to take a side trip to RCRA, the Resource Conservation and Recovery Act. RCRA

31 So what about unwanted medicines and the Universal Waste Rule? To answer this we have to take a side trip to RCRA, the Resource Conservation and Recovery Act. Currently, hospitals that generate pharmaceutical wastes on RCRA’s so-called P- and U-lists (e.g., warfarin, physostigmine, and chemotherapy drugs) are classified as hazardous waste generators. However, these lists have not been updated since RCRA was written in the 1970’s, despite dramatic expansion of the universe of pharmaceuticals.

32 So what about unwanted medicines and the Universal Waste Rule? To answer this we have to take a side trip to RCRA, the Resource Conservation and Recovery Act. Currently, hospitals that generate pharmaceutical wastes on RCRA’s P- and U-lists (e.g., warfarin, physostigmine, and chemotherapy drugs) are classified as hazardous waste generators. However, these lists have not been updated since RCRA was written in the 1970’s, despite dramatic expansion of the universe of pharmaceuticals. Some pharmaceuticals have ingredients with characteristics that cause them to ‘designate’ as hazardous waste when disposed, even if they are not on the P or U lists.

33 So what about unwanted medicines and the Universal Waste Rule? To answer this we have to take a side trip to RCRA, the Resource Conservation and Recovery Act. Currently, hospitals that generate pharmaceutical wastes on RCRA’s P- and U-lists (e.g., warfarin, physostigmine, and chemotherapy drugs) are classified as hazardous waste generators. However, these lists have not been updated since RCRA was written in the 1970’s, despite dramatic expansion of the universe of pharmaceuticals. Some pharmaceuticals have ingredients with characteristics that cause them to ‘designate’ as hazardous waste when disposed, even if they are not on the P or U lists. Note: pharmaceutical waste generated by households is exempt from the state Dangerous Waste and the federal RCRA rules. However, local jurisdictions responsible for municipal waste management may disallow household hazardous waste from regular solid waste, septic, or sewer disposal routes, as in the case of Snohomish County, Kitsap County, and the City of Seattle. EPA, Pharmaceuticals and U-Waste:

34 So what about unwanted medicines and the Universal Waste Rule? To answer this we have to take a side trip to RCRA, the Resource Conservation and Recovery Act. Currently, hospitals that generate pharmaceutical wastes on RCRA’s P- and U-lists (e.g., warfarin, physostigmine, and chemotherapy drugs) are classified as hazardous waste generators. However, these lists have not been updated since RCRA was written in the 1970’s, despite dramatic expansion of the universe of pharmaceuticals. Some pharmaceuticals have ingredients with characteristics that cause them to ‘designate’ as hazardous waste when disposed, even if they are not on the P or U lists. Note: pharmaceutical waste generated by households is exempt from the state Dangerous Waste and the federal RCRA rules. However, local jurisdictions responsible for municipal waste management may disallow household hazardous waste from regular solid waste, septic, or sewer disposal routes, as in the case of Snohomish County, Kitsap County, and the City of Seattle. “Approximately 4-5 percent of pharmaceutical products designate under the federal RCRA regulations as hazardous waste. If RCRA P and U lists were updated to include comparable products developed in the last 30 years, the number of products designating as hazardous waste would approach 15%.” Charlotte Smith, Founder of PharmEcology EPA, Pharmaceuticals and U-Waste:

Reasons to Manage all Consumer Take- Back Drugs Under the U-Waste Rules and as Hazardous Waste Nursing homes could dispose of medicines with a U-Waste reverse distributor. Best management practice for the environment.

Reasons to Manage all Consumer Take- Back Drugs Under the U-Waste Rules and as Hazardous Waste? Nursing homes could dispose of medicines with a U-Waste reverse distributor. Best management practice for the environment. Meets the intent of RCRA. Too difficult to separate into hazardous and non-hazardous during collection.

Reasons to Manage all Consumer Take- Back Drugs Under the U-Waste Rules and as Hazardous Waste? Nursing homes could dispose of medicines with a U-Waste reverse distributor. Best management practice for the environment. Meets the intent of RCRA. Too difficult to separate into hazardous and non-hazardous during collection. Tighter security and tracking to prevent diversion. Most medicines in Washington State designate as state only dangerous waste (hazardous waste).

UNITED STATES POSTAL SERVICE Issues include: – Postal regulations vis-à-vis drug mail- back programs. – Cost of mailers and postage. – Management of controlled substances (align with other reg’s). – Options for viable/ legal recipients (e.g. DEA agents; deputized haz. waste incinerators; reverse distributors).