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Publication 52 - Hazardous, Restricted, and Perishable Mail service > 4 Restricted Matter > 45 Other Restricted Materials > 453 Controlled Substances and Drugs

453 Controlled Substances and Drugs

453.1 Definitions

453.11 Controlled Substances

A controlled substance is any anabolic steroid, narcotic, hallucinogenic, stimulant, or depressant drug identified in Schedules I through 5 of the Controlled Substances Act in 21 The statesC. 801 and the implementing regulations in 21 CFR 1300.

Controlled substances include poisons, compositions containing poisons, poisonous drugs and medicines, or materials that may impale or injure within the intent and meaning of 18 U.s.a.C. 1716.

453.12 Drugs

The term "drug" refers to:

1. Prescription drugs which are licensed medicines that crave a written order by a medical medico or pharmacist earlier they can be obtained. Certain poisonous (toxic) drugs and medicines may be discipline to the requirements for Division 6.ane materials in Chapter 3.
2. Over-the-counter drugs which are medicines that can exist obtained without a prescription. This includes patent medicines and related items such every bit aspirin, antiseptics, cold remedies, diet pills, and cosmetic medicines that practice non incorporate a controlled substance and are not poisonous drugs or medicines.

453.13 Drug Paraphernalia

The term "drug paraphernalia" refers to whatsoever equipment, product, or cloth primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human being body a controlled substance.

Examples of drug paraphernalia are items primarily intended or designed for use in ingesting, inhaling, or otherwise introducing marijuana, cocaine, hashish, hashish oil, PCP, or amphetamines into the man trunk, such every bit metallic, wooden, acrylic, drinking glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls; h2o pipes, chamber pipes, carburetor pipes, electric pipes, ice pipes or chillers, and air-driven pipes; carburetion tubes and devices; smoking and carburetion masks; roach clips (i.e., objects used to hold burning textile that is too small or curt to be held in the hand); miniature spoons with level capacities of one/ten cubic centimeter or less; chillums; bongs; wired cigarette papers; and cocaine freebase kits.

453.131 Conclusion

In determining whether an particular constitutes drug paraphernalia, in addition to all other logically relevant factors, these factors may exist considered:

1. Oral or written instructions or other descriptive materials provided with the item that explain or depict its use.
2. National and local advertising on its use.
3. The fashion in which the item is displayed for sale.
4. Whether the owner, or anyone in control of the detail, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products.
5. Direct or coexisting evidence of the ratio of sales of the items to the total sales of the business enterprise.
6. The being and telescopic of legitimate uses of the particular in the community.
7. Skilful testimony on its utilise.

453.132 Exceptions

The standards in 453.13 and 453.131 apply neither to any person authorized by local, state, or federal law to manufacture, possess, or distribute items described in 453.13 and 453.131; nor to whatever item that, in the normal lawful course of concern, is sold through the post and traditionally intended for utilise with tobacco products, including any pipe, paper, or accessory.

453.two Mailer Responsibility

The mailer is fully responsible for the following:

1. Ensuring compliance not only with Postal service regulations, but also with all other federal laws and regulations, such equally the Poisonous substance Prevention Packaging Act and the Consumer Product Condom Human activity, and with all local laws and regulations governing distribution of unsolicited samples.
2. Being aware of other characteristics of an article or substance, such as its flammable, toxicity, or corrosive characteristics that may affect mailability.

453.three Mailability

453.31 Controlled Substances

If the distribution of a controlled substance is unlawful under 21 United states of americaC. 801–971 or any implementing regulation in 21 CFR Affiliate II, then the mailing of the substance is also unlawful under 18 U.s.C. 1716.

Controlled substances and drugs that contain controlled substances are adequate in the domestic post only under the following conditions:

1. For mailable controlled substances, generally both the mailer and addressee must come across either of the following conditions:
1. Be registered with the Drug Enforcement Administration (DEA).
2. Exist exempted from DEA registration, such every bit armed forces, civil defense, and police enforcement personnel, in performing official duties.
2. For mail-back programs conducted in accordance with 453.seven.
3. For prescription medicines containing mailable narcotic drugs (controlled substances), when mailed by drug manufacturers or their registered agents, pharmacies, medical practitioners, or other authorized dispensers as permitted by 21 CFR 1307.xi or in compliance with any regulation of the Food and Drug Administration or other applicable constabulary.

453.32 Drugs (Other Than Controlled Substances)

All prescription, nonprescription, and patent medicines and related items, including solicited and unsolicited samples of such items, that are not considered to be controlled substances under 453.xi, are permitted to exist mailed equally follows:

1. For prescription medicines containing a nonnarcotic drug(s), only a pharmacist or medical practitioner, etc., who dispenses the medicine may mail service such substances to the patients nether their care.
2. For nonprescription medicines, the mailer must come across all applicable federal, land, or local laws that may apply (such every bit the Toxicant Prevention Packaging Human activity of 1970 in 15 U.South.C. 1471(2) and the Consumer Production Safety Commission requirements in 16 CFR 1700).

453.33 Poisonous Drugs and Medicines

Poisonous drugs and medicines may exist sent only from the manufacturer or dealer to licensed physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, and veterinarians (18 United statesC. 1716). Some poisonous drugs are subject area to the requirements for Division 6.ane materials in Chapter iii.

453.34 Pocket-sized Amounts for Police force Enforcement Purposes

Null in this department precludes the mailing of small amounts of unknown thing suspected of containing controlled substances to a federal, state, or local law enforcement agency for law enforcement purposes. Such mailings must comply with the applicable packaging requirements in 453.4.

453.35 Drug Paraphernalia

It is unlawful to utilize the mail service to transport drug paraphernalia under the Controlled Substances Act. If utilise of the post to transport an article is unlawful under the Controlled Substances Act, the article also is nonmailable (see 453.13).

453.36 Return of Prescription Drugs

Mailers may use trade render service to return prescription drugs for purposes of drug recalls; voluntary manufacturer withdrawals; and dispensing errors such as incorrect drug, dosage, or strength, every bit permitted by 21 CFR 1307.11 or other applicable police. The mailpiece must be addressed to the manufacturer or its registered agent. Manufacturers or their registered agents must furnish mailing containers to their customers for the purpose of mailing back the identified drugs. Manufacturers or their registered agents must employ merchandise return service (see DMM 505.3.0) with First-Class Mail or Priority Postal service for these mailpieces. Manufacturers or their agents continue to be responsible for maintaining records in compliance with whatsoever regulation of the Drug Enforcement Administration and/or the Nutrient and Drug Assistants.

453.37 Hemp-based Products

For purposes of this department, "hemp" shall have the meaning provided under federal law, including Section 10113 of the Agricultural Improvement Human activity of 2018, Pub. L.115-334 (7 U.Due south.C. § 1639o), or any successor provision.

Hemp and hemp-based products, including cannabidiol (CBD) with the tetrahydrocannabinol (THC) concentration of such hemp (or its derivatives) non exceeding a 0.3 percent limit are permitted to be mailed only when:

1. The mailer complies with all applicable federal, state, and local laws (such as the Agricultural Act of 2014 and the Agricultural Improvement Deed of 2018) pertaining to hemp product, processing, distribution, and sales; and
2. The mailer retains records establishing compliance with such laws, including laboratory test results, licenses, or compliance reports, for no less than 2 years after the appointment of mailing.

453.iv Packaging and Marking

Deeply packet all mailable drugs so that the contents cannot become damaged or dislodged during mailing. The post-obit conditions apply:

1. Controlled substances. The inner packaging of any mailpiece containing a mailable controlled substance must exist marked and sealed in accordance with the applicable provisions and regulations of the Controlled Substances Human activity (come across 453.11). The inner packaging is also labeled to prove the prescription number and the name and address of the chemist's shop, practitioner, or other person dispensing the prescription and must exist deeply held within a plain outer wrapper or packaging. No markings of any kind that indicate the nature of the contents may appear on the exterior of the mailpiece. The general packaging requirements in DMM 601.1-7 likewise utilize.
2. Drugs and Medicines. Drugs and Medicines. Except for promotional samples equally described in 453.4 c, each mailpiece containing a mailable drug or medicine (that does not contain a controlled substance) must be held in a plain outer wrapper or packaging.
3. Promotional Samples. A promotional sample package containing a mailable over the counter, not-controlled, non-prescription drug or medicine may acquit a cursory description of the sample equally well every bit the mark "Sample Enclosed" on the exterior packaging of the mailpiece.

453.5 Rulings

Rulings must be based on the chemical composition of a product; the composition of commercial products is ever–changing-eastward.yard., the packaging declares a "new and improved formula."

Requests for rulings must include the merchandise proper noun of the production, as well as information regarding any known hazardous ingredients. A generic description of the item (e.g., "tranquilizers") is not sufficient. Requests for rulings are directed to the local postmaster (see 215.3).

453.6 Nonmailable Matter Establish in the Mails

Nonmailable controlled substances, drugs, and drug paraphernalia discovered in the mailstream must be immediately reported in accordance with POM 139.117.

453.vii Mail-dorsum Programs

Effective Oct nine, 2014, the U.S. Department of Justice, Drug Enforcement Assistants (DEA), published the Federal Register terminal 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 utilize of DEA authorized mail-back collectors (mailers) or police force enforcement entities to conduct postal service-back programs. Though these programs authorize ultimate users who accept lawfully obtained unused or unwanted pharmaceuticals to transfer controlled substance pharmaceuticals to authorized mail-dorsum collectors for the purpose of disposal, USPS potency to conduct mail-back programs is subject to the following conditions:

1. General

DEA registrants wishing to go 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 managing director, Product Nomenclature prior to the implementation of any post-dorsum program. Mail service-dorsum programs may but be authorized within the community territory of the The states (the 50 States, the District of Columbia, and Puerto Rico).

2. Packaging

Authorized DEA registrants participating in a post-back program must provide users with ready-fabricated packaging. All packaging used in mail-back programs must:

1. Exist nondescript and must not include any markings or other information that might betoken that the package contains controlled substances.
2. Be h2o- and spill-proof, tamper-evident, tear-resistant, and sealable.
3. Be preaddressed for commitment to the authorized post-back collector's registered address or the participating constabulary enforcement's physical address.
4. Take postage pre-paid using one of the following products:
1. Priority Mail Return Service,
2. Showtime-Class Parcel Return Service, or
3. Business concern Reply Postal service parcels.
5. Be accompanied by instructions for the user that describes the process for mailing back the packet, and other required information.
3. Labels

Prior to requesting dominance, applicants (mailers) must:

1. Implement a procedure for generating labels including unique Intelligent Mail package barcodes, prepared in accordance with DMM 708.five.1, Publication 199, and the Package Labeling Guide. Publication 199 and the Bundle Labeling Guide are available on PostalPro at http://postalpro.usps.com/ .
2. Applicants must obtain written approving for their labels and barcode quality from the National Customer Support Center (NCSC) prior to submitting their request for authorization to conduct a postal service-back programme.
4. Authorization

Mailers wishing to conduct a post-back program must submit a letter of request to the managing director, Product Classification (run into DMM 608.8.1 for accost). Requests must include:

1. The registrant'south name, accost, and DEA certificate of registration;
2. The authorized mail-dorsum collector'south DEA-registered location;
3. An irrevocable $50,000 surety bond or letter of credit equally proof of sufficient financial responsibility to embrace disposal costs if the vendor ceases doing business organisation to cover destruction costs of balance mail-dorsum envelopes that are in Mail service possession. The surety bail or letter of credit must be issued in the proper name of the vendor seeking the authorization and must name the Postal service as the casher or obligee;
4. A letter of approval from the NCSC for each label blazon used to conduct their mail-dorsum program; and
5. Sample mailpieces and labels intended for use with their postal service-dorsum program.
5. Discontinuation

In the outcome an authorized mail-back collector terminates, transfers, or discontinues business, that collector must provide the manager, Product Nomenclature with the proper noun, registered accost, and registration number of the postal service-back collector that will receive the remaining mail service-back packages, in accord with DEA regulations.

453.8 Undeliverable Medicines

The disposition of undeliverable mailpieces containing drugs and medicines is governed by POM 691.52

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Source: https://pe.usps.com/text/pub52/pub52c4_019.htm

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