§ 2540 — Requirements for pharmaceutical activities not carried on in a pharmacy [Effective June 30, 2026]

(a) Drugs may not be manufactured, packed, packaged, or distributed within this State unless done so under the personal and immediate supervision of a person approved by the Board after investigation and determination by the Board as set forth in the Board’s rules and regulations.

(b) A person may not operate a pharmaceutical establishment to manufacture, pack, package, or distribute on a wholesale basis to persons other than the ultimate consumer any drugs without first obtaining from the Board a license to operate a pharmaceutical establishment. This subchapter also applies to the activities of a reverse distributor who acts as an agent for a person permitted to operate a pharmaceutical establishment by receiving, inventorying, and managing the disposition of outdated or otherwise nonsalable drugs. A license issued pursuant to this subchapter must be available for inspection by authorized persons.

(c) A person who has a permit to operate a pharmaceutical establishment is subject to board rules and regulations with respect to the storage and handling of drugs and to the establishment and maintenance of drug distribution records, and must comply with federal, state, and local law.

(d) As set forth in the Board’s rules and regulations, a license to operate a pharmaceutical establishment issued pursuant to this subchapter terminates automatically upon a change in ownership, the termination of the pharmaceutical establishment’s legal existence, or the discontinuance of business or professional practice.

(e) Nothing in this subchapter may be construed to apply to pharmacies.

Legislative History

Code 1935, § 956B; 41 Del. Laws, c. 87, § 3 ; 24 Del. C. 1953, § 2571; 53 Del. Laws, c. 90, § 28 ; 59 Del. Laws, c. 318, § 6 ; 68 Del. Laws, c. 206, § 1 ; 76 Del. Laws, c. 167, § 1 ; 85 Del. Laws, c. 49, § 1