Title 48 — Foods and Drugs.

For the purposes of this chapter, the term: (1) “Distribute” means: (A) To sell any drug for resale; (B) To act as a broker, agent, distributor, jobber, or wholesaler of any drug; or (C) To otherwise negotiate a sale for the resale of any drug. (2) “Drug” means any substance as d…

No person shall: (1) Manufacture, distribute, or wholesale any drug in the District of Columbia (“District”) unless the person holds a license or registration as required by this chapter issued by the Mayor to manufacture, distribute, or wholesale drugs; (2) Manufacture, distribu…

(a) To obtain a license to manufacture, distribute, or wholesale any drug, any person who has a principal place of business in the District shall submit a completed application form with the required application fee to the Mayor and comply with the requirements of this chapter an…

The Mayor shall make available a license application form that requests: (1) The name of the applicant and the address of the place of business for which the applicant seeks a license; (2) If the applicant is a corporation, the name and address of each officer or director of the …

Prior to the expiration of a license, the Mayor shall mail a renewal notice to the licensee that includes: (1) The expiration date of the current license; (2) The date by which the renewal application must be received by the Mayor in order for the renewal license to be issued and…

The Mayor may issue a conditional license to a person if the person does not meet all of the requirements of this chapter, the rules issued pursuant to this chapter, or any applicable federal law, provided the failure to meet the requirements does not endanger the health, safety,…

(a) An out-of-state drug manufacturer, distributor, or wholesaler who conducts distribution activities within the District shall register with the Mayor on a form prescribed by the Mayor, renew the registration as required by rule, and pay the required registration fee. (b) A per…

(a) The Mayor shall conduct an on-site inspection of an applicant’s facility before a license is granted. (b) The Mayor, at any reasonable hour and consistent with constitutional guidelines, may enter a facility to conduct an announced or unannounced inspection of the facility to…

(a) If the Mayor determines that the conduct of a licensee presents an imminent danger to the health and safety of the residents of the District, the Mayor may suspend or revoke the license, or convert the license to a conditional license of the drug manufacturer, distributor, or…

(a) The Mayor may deny, suspend, or revoke a license, or convert the license to a conditional license, if the Mayor determines that: (1) The person has violated a provision of this chapter, the rules issued pursuant to this chapter, or any other applicable federal or District law…

A person who willfully violates § 48-702(1) is guilty of a misdemeanor, and, upon conviction, shall be fined not more than $5,000 for the first offense or $10,000 for the second or subsequent offense, imprisoned for not more than one year, or both. Each day that a violation conti…

Civil fines, penalties, and fees may be imposed as sanctions for any violation of this chapter or the rules issued pursuant to this chapter, pursuant to Chapter 18 of Title 2.

(a) If the Mayor determines that a hazardous condition exists that may endanger the health, safety, or welfare of the community, the Mayor may issue a cease and desist order to require a violator to cease operation immediately. Any person subject to a cease and desist order may a…

(a) The Mayor shall issue rules pursuant to this chapter in accordance with the provisions of subchapter I of Chapter 5 of Title 2. (b) The proposed rules shall include, but not be limited to: (1) A schedule of license fees; (2) Standards for the exemption of certain employees em…

This chapter shall not apply to any cosmetic unless the cosmetic is a drug as defined by § 201 of the Food, Drug and Cosmetic Act [21 U.S.C. § 321 ].