Title 21 CFR reference

This part applies to any person, partnership, corporation, or business firm in a State engaging in the wholesale distribution of human prescription drugs in interstate commerce.

The purpose of this part is to implement the Prescription Drug Marketing Act of 1987 by providing minimum standards, terms, and conditions for the licensing by State licensing authorities of persons who engage in wholesale distributions in interstate commerce of prescription drugs.

Blood(a) means whole blood collected from a single donor and processed either for transfusion or further manufacturing. Blood component(b) means that part of blood separated by physical or mechanical means. Drug sample(c) means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug. Manufacturer(d) means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug. Prescription drug(e) means any human drug required by Federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act. Wholesale distributionwholesale distribution(f) and means distribution of prescription drugs to persons other than a consumer or patient, but does not include: (1) Intracompany sales; (2) The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities that…

Every wholesale distributor in a State who engages in wholesale distributions of prescription drugs in interstate commerce must be licensed by the State licensing authority in accordance with this part before engaging in wholesale distributions of prescription drugs in interstate commerce.

(a) The State licensing authority shall require the following minimum information from each wholesale drug distributor as part of the license described in § 205.4 and as part of any renewal of such license: (1) The name, full business address, and telephone number of the licensee; (2) All trade or business names used by the licensee; (3) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of prescription drugs; (4) The type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and (5) The name(s) of the owner and/or operator of the licensee, including: (i) If a person, the name of the person; (ii) If a partnership, the name of each partner, and the name of the partnership; (iii) If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the State of incorporation; and (iv) If a sole proprietorship, the full name of the sole proprietor and the name of the business entity. (b) The State licensing authority may provide for a single license for a business entity operating more than one facility…

The State licensing law shall include the following minimum requirements for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees: Facilities.(a) All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall: (1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations; (2) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions; (3) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened; (4) Be maintained in a clean and orderly condition; and (5) Be free from infestation by insects, rodents, birds, or vermin of any kind. Security.(b) (1) All facilities used for wholesale drug distribution shall be secure from unauthorized entry. (i) Access from outside the premises shall…

(a) The State licensing authority shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage in wholesale distribution of prescription drugs within the State: (1) Any convictions of the applicant under any Federal, State, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances; (2) Any felony convictions of the applicant under Federal, State, or local laws; (3) The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances; (4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution; (5) Suspension or revocation by Federal, State, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances; (6) Compliance with licensing requirements under previously granted licenses, if any; (7) Compliance with requirements to maintain and/or make available to the State licensing authority or to Federal, State, or local law enforcement…

The State licensing authority shall require that personnel employed in wholesale distribution have appropriate education and/or experience to assume responsibility for positions related to compliance with State licensing requirements.

(a) State licensing laws shall provide for the suspension or revocation of licenses upon conviction of violations of Federal, State, or local drug laws or regulations, and may provide for fines, imprisonment, or civil penalties. (b) State licensing laws shall provide for suspension or revocation of licenses, where appropriate, for violations of its provisions.