Effective December 10, 2015, the Postal Service™ is revising Publication 52, Hazardous, Restricted, and Perishable Mail, to provide new standards applicable to mail-back programs of pharmaceutical drugs for the purpose of disposal.
On September 9, 2014, the Drug Enforcement Administration (DEA) published the Federal Register final rule titled “Disposal of Controlled Substances” (79 FR 53519-53570), that provided new regulations specific to the collection and disposal of controlled substances. This rule implements new regulations in the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances from ultimate users for the purpose of disposal, including authorized mail-back programs and the use of secured onsite collection receptacles.
In accordance with DEA regulations, authorized DEA registrants wishing to become controlled substances “mail-back collectors” must modify their DEA registration to conduct a mail-back program, and must have the ability to destroy the returned substances onsite. In addition, ultimate users must be provided with pre-paid, pre-addressed packaging. The DEA requires that packaging must:
n Be nondescript and not include any markings or other information that might indicate that the package contains controlled substances.
n Be water- and spill-proof, tamper-evident, tear-resistant, and sealable.
n Be preaddressed for delivery to the authorized collector’s registered address or the participating law enforcement’s physical address.
n Have postage pre-applied by the authorized collector.
n Have a unique identification number that enables the package to be tracked.
n Be accompanied by instructions for the user that describe the process for mailing back the package and other required information.
Once authorized by the DEA, mail-back collectors wishing to conduct mail-back programs must submit a letter of request to the manager, Product Classification (see 214 for address). Requests must include:
n The registrant’s name, address, and DEA certificate of registration;
n Samples of each mail-back system/container used by the applicant;
n The authorized mail-back collector’s registered location and the method of destruction consistent with DEA regulations; and
n An irrevocable $50,000 surety bond or letter of credit as proof of sufficient financial responsibility to cover disposal costs if the vendor ceases doing business to cover destruction costs of residual mail-back envelopes that are in Postal Service possession. The surety bond or letter of credit must be issued in the name of the vendor seeking the authorization and must name the Postal Service as the beneficiary or obligee.
In the event a DEA authorized mail-back collector terminates, transfers, or discontinues business, that collector must provide the manager, Product Classification, with the name, registered address, and registration number of the authorized mail-back collector that will receive the remaining mail-back packages in accordance with DEA regulations.
Publication 52, Hazardous, Restricted, and Perishable Mail
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4 Restricted Matter
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45 Other Restricted Materials
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453 Controlled Substances and Drugs
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453.3 Mailability
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453.31 Controlled Substances
[Revise the first paragraph of 453.31 to read as follows:]
If the distribution of a controlled substance is unlawful under 21 U.S.C. 801–971 or any implementing regulation in 21 CFR Chapter II, then the mailing of the substance is also unlawful under 18 U.S.C. 1716.
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[Renumber the current 453.31b as the new 453.31c and add a new 453.31b to read as follows:]
b. For mail-back programs conducted in accordance with 453.7.
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[Renumber current 453.7 as 453.8 and add new section 453.7 to read as follows:]
453.7 Mail-back Programs
Effective October 9, 2014, the U.S. Department of Justice, Drug Enforcement Administration (DEA), published the Federal Register final rule titled “Disposal of Controlled Substances” (79 CFR 53519-53570), where it provided new regulations specific to the collection and disposal of controlled substances. This regulation authorized the use of DEA authorized mail-back collectors (mailers) or law enforcement entities to conduct mail-back programs. Though these programs authorize ultimate users who have lawfully obtained unused or unwanted pharmaceuticals to transfer controlled substance pharmaceuticals to authorized mail-back collectors for the purpose of disposal, USPS authorization to conduct mail-back programs is subject to the following conditions:
a. General
DEA registrants wishing to become controlled substances “mail-back collectors” must obtain authorization from the DEA prior to conducting a mail-back program, and must have the ability to destroy the returned substances onsite. DEA-registered mail-back collectors must also obtain an authorization from the USPS manager, Product Classification prior to the implementation of any mail-back program. Mail-back programs may only be authorized within the customs territory of the United States (the 50 States, the District of Columbia, and Puerto Rico).
b. Packaging
Authorized DEA registrants participating in a mail-back program must provide users with ready-made packaging. All packaging used in mail-back programs must:
1. Be nondescript and must not include any markings or other information that might indicate that the package contains controlled substances.
2. Be water- and spill-proof, tamper-evident, tear-resistant, and sealable.
3. Be preaddressed for delivery to the authorized mail-back collector’s registered address or the participating law enforcement’s physical address.
4. Have postage pre-paid using one of the following products:
a. Priority Mail Return Service,
b. First-Class Package Return Service, or
c. Business Reply Mail parcels
5. Be accompanied by instructions for the user that describes the process for mailing back the package, and other required information.
c. Labels
Prior to requesting authorization, applicants (mailers) must:
1. Implement a process for generating labels including unique Intelligent Mail package barcodes, prepared in accordance with DMM 708.5.1, Publication 199, and the Parcel Labeling Guide. Publication 199 and the Parcel Labeling Guide are available on RIBBS at http://ribbs.usps.gov.
2. Applicants must obtain written approval for their labels and barcode quality from the National Customer Support Center (NCSC) prior to submitting their request for authorization to conduct a mail-back program.
d. Authorization
Mailers wishing to conduct a mail-back program must submit a letter of request to the manager, Product Classification (see DMM 608.8.1 for address). Requests must include:
1. The registrant’s name, address, and DEA certificate of registration;
2. The authorized mail-back collector’s DEA-registered location;
3. An irrevocable $50,000 surety bond or letter of credit as proof of sufficient financial responsibility to cover disposal costs if the vendor ceases doing business to cover destruction costs of residual mail-back envelopes that are in Postal Service possession. The surety bond or letter of credit must be issued in the name of the vendor seeking the authorization and must name the Postal Service as the beneficiary or obligee;
4. A letter of approval from the NCSC for each label type used to conduct their mail-back program; and
5. Sample mailpieces and labels intended for use with their mail-back program.
e. Discontinuation
In the event an authorized mail-back collector terminates, transfers, or discontinues business, that collector must provide the manager, Product Classification with the name, registered address, and registration number of the mail-back collector that will receive the remaining mail-back packages, in accordance with DEA regulations.
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We will incorporate these revisions into the next online update of Publication 52, Hazardous, Restricted, and Perishable Mail, which is available via Postal Explorer® at http://pe.usps.com.
— Product Classification,
Pricing, 12-10-15
