A controlled substance is 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 which are 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 be subject to the requirements for Division 6.1 materials in Chapter 3.
- Over-the-counter drugs which are medicines that can be obtained without a prescription. This includes 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.
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.
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 human body, such as metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls; water 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 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; chillums; bongs; wired cigarette papers; and cocaine freebase kits.
In determining whether an item constitutes drug paraphernalia, in addition to all other logically relevant factors, these factors may be considered:
- Oral or written instructions or other descriptive materials provided with the item that explain or depict its use.
- National and local advertising on its use.
- The manner in which the item is displayed for sale.
- 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.
- Direct or circumstantial evidence of the ratio of sales of the items to the total sales of the business enterprise.
- The existence and scope of legitimate uses of the item in the community.
- Expert testimony on its use.
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 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:
- 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.
- Being aware of other characteristics of an article or substance, such as its flammable, toxicity, or corrosive characteristics 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 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 acceptable in the domestic mail only under the following conditions:
- For mailable controlled substances, generally both the mailer and addressee must meet either of the following conditions:
- Be registered with the Drug Enforcement Administration (DEA).
- Be exempted from DEA registration, such as military, civil defense, and law enforcement personnel, in performing official duties.
- For mail-back programs conducted in accordance with 453.7.
- 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 1307.11 or in compliance with any regulation of the Food and Drug Administration or other applicable law.
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:
- 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.
- 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).
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.
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.
If the possession of any type of drug paraphernalia is unlawful under the Controlled Substances Act, the article also is nonmailable (see 453.13).
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 1307.11 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 505.3.0) 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.
Securely package all mailable drugs so that the contents cannot become damaged or dislodged during mailing. The following conditions apply:
- 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 is also labeled to show the prescription number and the name and address of the pharmacy, practitioner, or other person dispensing the prescription and 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 601.1-7 also apply.
- Drugs and Medicines. Drugs and Medicines. Except for promotional samples as described in 453.4c, 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.
- Promotional Samples. A promotional sample package containing a mailable over the counter, non-controlled, non-prescription drug or medicine may bear a brief description of the sample as well as the marking “Sample Enclosed” on the outside packaging of the mailpiece.
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 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).
Nonmailable controlled substances, drugs, and drug paraphernalia discovered in the mailstream must be immediately reported in accordance with POM 139.117.
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:
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).
Authorized DEA registrants participating in a mail-back program must provide users with ready-made packaging. All packaging used in mail-back programs must:
- Be nondescript and must not include any markings or other information that might indicate that the package contains controlled substances.
- Be water- and spill-proof, tamper-evident, tear-resistant, and sealable.
- Be preaddressed for delivery to the authorized mail-back collector’s registered address or the participating law enforcement’s physical address.
- Have postage pre-paid using one of the following products:
- Priority Mail Return Service,
- First-Class Package Return Service, or
- Business Reply Mail parcels.
- Be accompanied by instructions for the user that describes the process for mailing back the package, and other required information.
Prior to requesting authorization, applicants (mailers) must:
- 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 PostalPro at http://postalpro.usps.com/.
- 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.
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:
- The registrant’s name, address, and DEA certificate of registration;
- The authorized mail-back collector’s DEA-registered location;
- 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;
- A letter of approval from the NCSC for each label type used to conduct their mail-back program; and
- Sample mailpieces and labels intended for use with their mail-back program.
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.
The disposition of undeliverable mailpieces containing drugs and medicines is governed by POM 691.52