Reverse Distribution of 

Pharmaceuticals

Guidance for Minnesota healthcare providers

Minnesota Pollution Control Agency • 520 Lafayette Rd. N., St. Paul, MN 55155-4194 • www.pca.state.mn.us

651-296-6300 • 800-657-3864 • TTY 651-282-5332 or 800-657-3864 • Available in alternative formats

Waste/Hazardous waste #3.36b • June 2011

w-hw3-36b

Contents

What is reverse 

distribution? ..................1

When are pharmaceuticals 

subject to regulation? ...1

Minimizing waste..............2

MPCA requirements.........2

Other requirements ..........3

Sent for use by another 

party..............................3

Donating...........................3

Training use .....................3

More information ..............4

What is reverse distribution?

In the course of normal operations, health care providers and pharmacies accumulate 

pharmaceuticals that, for various reasons, they will not use. The health care industry has 

developed a management process for returning some of these pharmaceuticals to specialized 

brokers for management – sometimes with a monetary credit to the provider. This process is 

known as reverse distribution.

Although the Minnesota Pollution Control Agency (MPCA) and the U.S. Environmental 

Protection Agency (EPA) considered reverse-distributed pharmaceuticals products exempt 

from hazardous waste requirements, the MPCA has become aware that the majority of these 

pharmaceuticals are destroyed or disposed of, making them wastes subject to the Minnesota 

Hazardous Waste Rules. Whether a pharmaceutical is eligible for return credit does not affect

its product or waste status. In Minnesota, if a pharmaceutical is not used or reused for its 

intended purpose, it is a waste. The MPCA considers health care practitioners and pharmacies 

to be generators of these pharmaceutical wastes.

Nevertheless, the MPCA believes that the established reverse distribution system provides an 

environmentally protective method for handling waste pharmaceuticals. Therefore, it will 

allow Minnesota health care practitioners and pharmacies to manage certain pharmaceuticals 

through reverse distribution, subject to additional requirements discussed in this fact sheet.

When are pharmaceuticals subject to MPCA regulation?

When pharmaceuticals cannot or will not be used for their intended purpose, they are 

considered waste and are regulated by the MPCA. Assume a waste pharmaceutical is

hazardous unless you have evaluated it and have documentation showing it to be nonhazardous. For help evaluating pharmaceuticals, see MPCA hazardous waste fact sheet 

#4.45a, Evaluating Pharmaceutical Wastes at http://www.pca.state.mn.us/publications/whw4-45a.pdf. 

Product pharmaceuticals that will be used for their intended purpose and waste

pharmaceuticals that have been shown to be non-hazardous are exempt from the Hazardous 

Waste Rules as well as the MPCA reverse distribution requirements discussed in this fact 

sheet. However, they may still be regulated by the Minnesota Board of Pharmacy (Board) or 

the U.S. Drug Enforcement Administration (DEA).
Reverse Distribution of Pharmaceuticals • w-hw 3-36b • June 2011

page 2

Minimizing pharmaceutical waste 

Even though managing pharmaceuticals through the reverse distribution system may cost less than normal hazardous 

waste management, the cost is likely still considerable – even if you are eligible for return credit. By utilizing wasteminimization practices, you may be able to reduce not only your regulatory burden, but also your costs. The Minnesota 

Technical Assistance Program (MnTAP) has resources to help you to reduce pharmaceutical waste generation and costs. 

Contact MnTAP for assistance (see More information, page four).

MPCA requirements when using reverse distribution for pharmaceuticals

To be eligible to manage unevaluated or hazardous waste pharmaceuticals through a reverse distributor, you must:

Get a Hazardous Waste Identification Number (HWID) – also known as an EPA Identification Number – free from 

the MPCA. To get a HWID, complete and submit MPCA hazardous waste form #7.09, Notification of Regulated 

Waste Activity at http://www.pca.state.mn.us/publications/w-hw7-09.pdf. 

Ensure the reverse distributor you intend to use is licensed by the Board as a pharmaceutical manufacturer or 

wholesaler. If the pharmaceuticals are controlled substances regulated by the Board or DEA, the reverse distributor 

must also be a DEA Registrant.

Document that all pharmaceuticals that (1) have not been evaluated or (2) would be hazardous waste in Minnesota 

will be disposed of according to hazardous waste disposal requirements. Documentation should include at least:

° An agreement between you and your reverse distributor stipulating that disposal of those pharmaceuticals will

meet hazardous waste disposal requirements; and

° A management plan from the reverse distributor listing the identity and location of the hazardous waste disposal 

facility or facilities that will ultimately manage those pharmaceuticals.

Accumulate and ship for reverse distribution only pharmaceutical wastes that you originally legally possessed as 

products. For questions on legal possession, contact the Board (see More information, page four). You may not accept 

or ship for reverse distribution any wastes that you have accepted from households or another generator.

Accumulate and ship for reverse distribution only pharmaceuticals in closed, original manufacturer or appropriate 

dispensing containers that are labeled with the identity of the pharmaceutical. Containers that formerly held 

pharmaceuticals may also be shipped if they are closed and labeled with the identity of the pharmaceutical they held, 

and your reverse distributor will accept them. Wrappers and backing materials are not eligible for this addition.

Label each pharmaceutical container accumulated for reverse distribution with one of the phrases: Reverse 

Distribution, Pharmaceuticals for Reverse Distribution, or Expired Pharmaceuticals; or accumulate the closed 

pharmaceutical containers in an open or closed box, bin or other accumulation container labeled with one of these 

phrases.

Maintain the following records at your site for at least three years from the shipping date:

° Shipping record (obtain or prepare this immediately) that includes at least the date and amount of the shipment 

by either weight or container count and the name and address of the reverse distributor.

° Disposal record (obtain from your reverse distributor within 40 days) that includes at least the date of shipment

to the reverse distributor and, for each pharmaceutical in the shipment: the identity, weight or unit count, 

hazardous waste code, and hazardous waste disposal method.

Comply with all requirements, limitations, and prohibitions of your chosen reverse distributor.

Comply with all applicable requirements of the Board, DEA, U.S. Department of Transportation (DOT), and any 

other applicable federal, state, or local law.
Reverse Distribution of Pharmaceuticals • w-hw 3-36b • June 2011

page 3

Other hazardous waste requirements

Do not count reverse-distributed pharmaceuticals when determining your hazardous waste generator size. 

Pharmaceuticals transported within a reverse-distribution system need not be accompanied by a hazardous waste manifest. 

However, if classified as a hazardous material by the DOT, a pharmaceutical may still be subject to the DOT's Hazardous 

Materials Regulations (HMR) requirements. Pharmaceuticals originally shipped to you as 'ORM-D' consumer 

commodities may remain eligible for the 'ORM-D' allowances under the HMR when they become waste shipped for 

reverse distribution. For questions on the HMR, contact the DOT (see More information, page four).

If you are located:

Within the seven-county metropolitan area (Anoka, Carver, Dakota, Hennepin, Ramsey, Scott, or Washington

County) – contact your county regulator for county-specific reporting and licensing requirements (see More 

information, page four).

Outside the seven-county metropolitan area – and you generate less than 100 pounds annually of 'countable' 

hazardous waste, you do not need to obtain a Hazardous Waste Generator License nor pay annual fees to the MPCA. 

You must still complete and submit a License Application every three years. The MPCA will notify you when you 

need to complete an Application.

Pharmaceutical manufacturers and wholesalers are not eligible for the reduced requirements for reverse distribution 

discussed in this fact sheet. Pharmaceutical wastes they generate or receive through a reverse-distribution system are

subject to full hazardous waste requirements.

Reverse-distributed pharmaceuticals not managed according to the requirements discussed in this fact sheet remain fully 

regulated wastes subject to all normal requirements of the Minnesota Hazardous Waste Rules.

Pharmaceuticals sent for use by another party

Pharmaceuticals that can and will be used for their intended purpose remain products not subject to MPCA requirements. 

Health care practitioners and pharmacies who intend to ship pharmaceuticals they cannot use to another party for use, 

however must be able to document that those pharmaceuticals will be used as intended.

Donating pharmaceuticals

Donating pharmaceuticals for legitimate use by charitable organizations is allowed by the MPCA; however, the 

practitioner or pharmacy must be able to document a reasonable belief that the donated pharmaceuticals will be used for 

their intended purpose by the receiving organization. Both the donor and receiver may also need to meet additional state 

and federal requirements relating to pharmaceutical possession and export. The MPCA cautions that, unless carefully 

planned in partnership with a responsible relief agency, many such well-intentioned donations end up being abandoned at 

their destination and remain the legal responsibility of the donor.

Training use

Pharmaceuticals may be supplied in forms (such as some pre-filled dispensing instruments) that require training for proper 

use. For training purposes, the MPCA previously allowed the use of unevaluated or hazardous expired pharmaceuticals 

that would not be administered to humans or animals. However, the MPCA has become aware that reasonable nonpharmaceutical training alternatives exist for the majority of training needs. Therefore, it will no longer allow training use 

of unevaluated or hazardous expired pharmaceuticals for which reasonable alternatives exist. 

In the unusual case that a training product is not available, the training program must document that obtaining or 

constructing a training-only product would be unreasonable before using an unevaluated or hazardous expired 

pharmaceutical for training.
Reverse Distribution of Pharmaceuticals • w-hw 3-36b • June 2011

page 4

More information

Your metropolitan county and the MPCA have staff available to answer waste management questions. For more 

information, contact your metropolitan county hazardous waste office or your nearest MPCA regional hazardous waste 

staff. For information about waste reduction, contact the Minnesota Technical Assistance Program. 

Metro County Hazardous Waste Offices

Anoka................................................763-422-7093

Carver ............................................. 952-361-1800

Dakota ............................................. 952-891-7557

Hennepin ......................................... 612-348-3777

Ramsey ........................................... 651-266-1199

Scott..................................................952-496-8475

Washington.......................................651-430-6655

Websites.................. http://www.co.[county].mn.us

Minnesota Pollution Control Agency

Toll free (all offices).................... 1-800-657-3864

Brainerd ........................................... 218-828-2492

Detroit Lakes ....................................218-847-1519

Duluth ..............................................218-723-4660

Mankato ...........................................507-389-5977

Marshall ...........................................507-537-7146

Rochester ..........................................507-285-7343

St. Paul .............................................651-296-6300

Willmar ............................................320-214-3786

Website .......................http://www.pca.state.mn.us

Minnesota Board of Pharmacy

Statewide .......................................... 651-201-2825

Website .............. http://www.phcybrd.state.mn.us/

Minnesota Technical Assistance Program

Toll free .........................................1-800-247-0015

Metro area ........................................ 612-624-1300

Website .......................http://www.mntap.umn.edu 

Minnesota Department of Transportation

Hazardous materials...................651-215-6330

Website 

... http://www.dot.state.mn.us/cvo/hazmat.html

U.S. Department of Transportation

Hazardous materials......................1-800-467-4922

Website............ http://www.phmsa.dot.gov/hazmat

U.S. Drug Enforcement Administration

Office of Diversion Control ..........1-800-882-9539

Website.......... http://www.deadiversion.usdoj.gov/