Controlled substances include any anabolic steroid, 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.
The term “drug” refers to:
- Prescription Drugs: Licensed medicines that require a written order by a medical doctor or pharmacist before they can be obtained. Certain poisonous (toxic) drugs and medicines may require Division 6.1 material handling as described in Chapter 3.
- Over-the-Counter (OTC) Drugs: Medicines that can be obtained without a prescription, such as patent medicines, aspirin, antiseptics, cold remedies, diet pills, and cosmetic medicines that do not contain a controlled substance and are not poisonous drugs or medicines.
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 a controlled substance into the human body.
Examples of drug paraphernalia include, but are not limited to:
- Ingestion/Inhalation Devices: Items such as metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes (with or without screens); water pipes; chamber pipes; smoking and carburetion masks; carburetor pipes; chillums; electric pipes; ice pipes or chillers; air-driven pipes; and bongs.
- Other Instruments: Roach clips (i.e., objects used to hold burning material that is too small or short to be held in the hand); miniature spoons with level capacities of 1/10 cubic centimeter or less; wired cigarette papers; cocaine freebase kits; and carburetion tubes.
In determining whether an item constitutes drug paraphernalia, in addition to all other logically relevant factors, the following factors may be considered:
- Descriptive Materials: Oral or written instructions or other descriptive materials provided with the item that explain or depict its use.
- Advertising: National and local advertising for the item‘s use.
- Sales Display: The way the item is displayed for sale.
- Supplier Credibility: Whether the owner, or anyone in control of the item, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products.
- Sales Ratio: Direct or circumstantial evidence of the item‘s sales relative to total business sales
- Legitimate Use: The existence and scope of legitimate uses of the item in the community.
- Expert Testimony: Expert testimony on its use.
The standards in 453.13 and 453.131 do not apply to any person legally authorized by local, state, or federal law to manufacture, possess, or distribute items described in 453.13 and 453.131, nor to any item that, in the normal lawful course of business, is sold through the mail and traditionally intended for use with tobacco products, including any pipe, paper, or accessory.
The mailer is fully responsible for the following:
- Regulatory Compliance: Ensuring compliance with Postal Service regulations, as well as federal, state, and local laws governing distribution (e.g., the Poison Prevention Packaging Act and the Consumer Product Safety Act), and regulations governing distribution of unsolicited samples.
- Material Awareness: Understanding characteristics of an article or substance, such as its flammability, toxicity, or corrosiveness that may affect mailability.
If the distribution of a controlled substance is unlawful under 21 U.S.C. § 801-971 or any implementing regulation in 21 CFR Chapter 2, 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:
- Authorized Mailers: Both the mailer and addressee must meet either of the following conditions:
- Registration with DEA: Be registered with the Drug Enforcement Administration (DEA).
- Exemption from DEA Registration: Be exempted from DEA registration, such as military, civil defense, and law enforcement personnel, in performing official duties.
- Mail-Back Programs: Mail-back programs conducted in accordance with 453.7.
- Prescription Medications: 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 § 1307.11, or in compliance with any regulation of the FDA or other applicable law.
Prescription, nonprescription, and patent medicines and related items, including solicited and unsolicited samples, that are not considered to be controlled substances under 453.11, are permitted to be mailed as follows:
- Prescription Medicines (Nonnarcotic): Only a pharmacists, medical practitioners, or other authorized dispensers may mail nonnarcotic prescription medications to patients under their care.
- Nonprescription Medicines: The mailer must meet all applicable federal, state, and local laws that may apply (refer to 453.2).
Poisonous drugs and medicines are mailable only from manufacturers or dealers to licensed medical professionals, including physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, and veterinarians (18 U.S.C. § 1716). Certain poisonous drugs are subject Division 6.1 materials requirements in Chapter 3.
Mailing of small amounts of unknown matter suspected to contain controlled substances to federal, state, or local law enforcement agencies, for law enforcement purposes, is permissible provided all applicable packaging requirements in 453.4 are met.
Mailing drug paraphernalia is illegal under the Controlled Substances Act. Any article deemed unlawful under the Controlled Substances Act is prohibited from mailing (refer to 453.13).
Mailers may use USPS Returns 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 § 1307.11 or other applicable law.
Mailers must address returns to the manufacturer or registered agent and utilize USPS Returns Service via Priority Mail Return service (refer to DMM 505.3.0). Manufacturers or their registered agents must supply mailing containers and maintain DEA or FDA regulatory compliance records.
For purposes of this section, "hemp" refers to the definition provided under federal law, including Section 10113 of the Agricultural Improvement Act of 2018, Pub. L.115-334 (7 U.S.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) not exceeding a 0.3 percent limit are permitted to be mailed domestically only when the mailer:
- Complies with all applicable federal, state, and local laws, including U.S. Department of Agriculture approved plans for hemp production, processing, distribution, and sales (7 CFR Part 990).
- Retains records establishing compliance with such laws and plans, including laboratory test results, licenses, or compliance reports, for no less than 3 years after the date of mailing.
Shipments of hemp and hemp-based products, including CBD, are prohibited in international mail, including items for delivery to overseas Army Post Office, Fleet Post Office, and Diplomatic Post Office addresses (APO/FPO/DPO).
All mailable drugs require secure packaging to prevent damage or dislodgement during transit. Specific packaging conditions include:
- Controlled substances: Inner packaging for controlled substances must be marked and sealed in accordance with the applicable provisions and regulations of the Controlled Substances Act (refer to 453.11). This packaging must be labeled to display the prescription number, as well as the name and address of the pharmacy, practitioner, or other person dispensing the prescription. The package must be securely held within a plain outer wrapper or packaging with no markings indicating its contents. General packaging requirements in DMM 601.1-7 also apply.
- Drugs and Medicines: Mailable drugs and medicines that do not contain controlled substances, except for promotional samples per item c. (below), must be enclosed in a plain outer wrapper or packaging.
- Promotional Samples: Promotional samples of mailable OTC, non-controlled, non-prescription drugs or medicines may display a brief description of the sample, as well as the marking "Sample Enclosed", on the outside packaging of the mailpiece.
Product rulings depend on the chemical composition , which may vary due to formulation updates (-e.g., "new and improved" versions).
Requests for rulings must include the product‘s trade name and information about any known hazardous ingredients. Generic descriptions (e.g., "tranquilizers") are not sufficient. Requests are directed to the local postmaster (refer to 215.3).
Nonmailable controlled substances, drugs, and drug paraphernalia discovered in the mailstream must be immediately reported in accordance with POM 139.117.
Authorized DEA registrants who wish to receive lawfully obtained unused or unwanted pharmaceuticals from ultimate users for the purpose of disposal must obtain Postal Service authorization. Mail-back programs may only be authorized within the customs territory of the U.S. (the 50 states, D.C., and Puerto Rico) and are subject to the following conditions:
- DEA Authorization: DEA registrants wishing to serve as mail-back collectors must secure authorization from the DEA prior to conducting a mail-back program and must have the ability to destroy the returned substances onsite.
- Postal Service Authorization: DEA-registered mail-back collectors must also obtain authorization from the Postal Service before implementing any mail-back program by submitting a letter of request to the director, Product Classification (refer to 214 for contact information). The letter of request must include:
- Registrant‘s Information: Name, address, and DEA certificate of registration.
- Mail-Back Collector‘s Registered Location: DEA-registered address.
- Disposal Cost Coverage: An irrevocable $50,000 surety bond or letter of credit as proof of sufficient financial responsibility to cover disposal costs of any residual mail-back envelopes in Postal Service possession if the vendor ceases operations. 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.
- Label Approval: NCSC letter of approval for each label type used to conduct the mail-back program.
- Sample Mailpieces: Those intended for use with the mail- back program.
Authorized mail-back participants must provide mailers with ready-made packaging. All packaging used in mail-back programs must adhere to the following:
- Nondescript: Does not include any markings or other information that might indicate that the package contains controlled substances.
- Durable: Water- and spill-proof, tamper-evident, tear-resistant, and sealable.
- Pre-addressed: Pre-addressed for delivery to the authorized mail-back collector‘s registered address or the participating law enforcement‘s physical address.
- Postage Prepaid: Using one of the following products:
- Priority Mail Return service.
- Business Reply Mail parcels.
- Instructions: Contains directions for the return process.
Applicants must establish a label generation process using unique Intelligent Mail package barcodes per DMM 708.5.1, Publication 199, and the Parcel Labeling Guide. (available at https://postalpro.usps.com).
Approval for label and barcode quality must be obtained from the National Customer Support Center (NCSC) before requesting authorization.
Mail-back collectors transferring or discontinuing operations must notify the director, Product Classification (refer to 214 for contact information). If transferring operations, the authorized collector must provide the name, registered address, and registration number of the new mail-back collector who will receive the remaining mail- back packages, in accordance with DEA regulations.
The disposition of undeliverable mailpieces containing drugs and medicines is governed by POM 691.52.
