Delaware Code Title 24. Professions and Occupations § 2540. Requirements for pharmaceutical activities not carried on in a pharmacy

(a) Drugs, toilet preparations, dentifrices, and cosmetics 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 that the person is qualified by scientific or technical training, education, or experience to perform the duties of supervision that are necessary to protect public health, safety, and welfare.

(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, toilet preparations, dentifrices, or cosmetics without first obtaining from the Board a permit 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person permitted to operate a pharmaceutical establishment by receiving, inventorying, and managing the disposition of outdated or otherwise nonsalable drugs.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 permit 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) A permit to operate a pharmaceutical establishment issued pursuant to this subchapter terminates automatically upon a transfer of the controlling interest in the pharmaceutical establishment, upon the termination of the pharmaceutical establishment's legal existence, or upon the discontinuance of business or professional practice.

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