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453 Controlled Substances and Drugs

453.1 Definitions

453.11 Controlled Substances

A controlled substance is any narcotic, hallucinogenic, stimulant, or depressant drug identified in Schedules I through V of the Controlled Substances Act in 21 U.S.C. 801 and the implementing regulations in 21 CFR 1300.

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

453.12 Drugs

The term “drug” refers to all prescription, nonprescription, and patent medicines and related items such as aspirin, antiseptics, cold remedies, diet pills, and cosmetic medicines that do not contain a controlled substance and are not poisonous drugs or medicines. Certain poisonous (toxic) drugs and medicines may be subject to the requirements for Division 6.1 materials in chapter 3.

453.13 Drug Paraphernalia

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

453.2 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 as the Poison Prevention Packaging Act and the Consumer Product Safety Act, 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.

453.3 Mailability

453.31 Controlled Substances

If the distribution of a controlled substance is unlawful under 21 U.S.C. 801 or any implementing regulation in 21 CFR 1300, then the mailing of the substance is also unlawful under 18 U.S.C. 1716.

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

  1. For mailable controlled substances, generally both the mailer and addressee must meet either of the following conditions:
    1. Be registered with the Drug Enforcement Administration (DEA).
    2. Be exempted from DEA registration, such as military, civil defense, and law enforcement personnel, in performing official duties.
  2. For prescription medicines containing mailable narcotic drugs (controlled substances), only a pharmacist or medical practitioner, etc., who dispenses the medicine may mail such substances to the patients under their care.
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 453.11, are permitted to be mailed as follows:

  1. For prescription medicines containing a nonnarcotic drug(s), only a pharmacist or medical practitioner, etc., who dispenses the medicine may mail such substances to the patients under their care.
  2. For nonprescription medicines, the mailer must meet all applicable federal, state, or local laws that may apply (such as the Poison Prevention Packaging Act of 1970 in 15 U.S.C. 1471(2) and the Consumer Product Safety Commission requirements in 16 CFR 1700).
453.33 Poisonous Drugs and Medicines

Poisonous drugs and medicines may be sent only from the manufacturer or dealer to licensed physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, and veterinarians (18 U.S.C. 1716). Some poisonous drugs are subject to the requirements for Division 6.1 materials in chapter 3.

453.34 Small Amounts for Law Enforcement Purposes

Nothing in this section precludes the mailing of small amounts of unknown matter 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

If the possession of any type of drug paraphernalia is unlawful under the Controlled Substances Act, the article also is nonmailable. See DMM 601.11.12 for more information.

453.36 Return of Prescription Drugs

Mailers may use merchandise return service to return prescription drugs for purposes of drug recalls; voluntary manufacturer withdrawals; and dispensing errors such as incorrect drug, dosage, or strength, as permitted by 21 CFR 1307.12 or other applicable law. 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 use merchandise return service (see DMM 507.9.0) with First–Class Mail or Priority Mail for these mailpieces. Manufacturers or their agents continue to be responsible for maintaining records in compliance with any regulation of the Drug Enforcement Administration and/or the Food and Drug Administration.

453.4 Packaging and Marking

The following conditions apply:

  1. Controlled substances. The inner packaging of any mailpiece containing a mailable controlled substance must be marked and sealed in accordance with the applicable provisions and regulations of the Controlled Substances Act (see 453.11). The inner packaging must be securely held within a plain outer wrapper or packaging. No markings of any kind that indicate the nature of the contents may appear on the outside of the mailpiece. The general packaging requirements in DMM 601.1–8 also apply.
  2. Drugs and Medicines. 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. No markings of any kind to indicate the nature of the contents may appear on the outside of the mailpiece. The general packaging requirements in DMM 601.1–8 also apply.

453.5 Rulings

Rulings must be based on the chemical composition of a product; the composition of commercial products is ever–changing-e.g., the packaging declares a “new and improved formula.”

Requests for rulings must include the trade name of the product, as well as information regarding any know 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 Found in the Mails

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

453.7 Undeliverable Medicines

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