2006 Delaware Code - Subchapter IV — Pharmaceutical Establishments Other Than Pharmacies

§ 2541. Requirements as to pharmaceutical activities not carried on in a pharmacy.

(a) No drugs, medicines, toilet preparations, dentifrices or cosmetics shall be manufactured, made, produced, packed, packaged or prepared within this State except under the personal and immediate supervision of such persons as may be approved by the Board after investigation and determination by the Board that they are qualified by scientific or technical training or experience to perform such duties of supervision as may be necessary to protect the public health and safety.

(b) No person shall manufacture, make, produce, pack, package, prepare or distribute on a wholesale basis to persons other than the ultimate consumer any such articles without first obtaining a permit so to do from the Board.

(c) The permit shall be subject to such rules and regulations with respect to storage and handling of drugs, the establishment and maintenance of drug distribution records, and compliance with federal, state and local law as the Board may from time to time adopt for the protection of the public health and safety.

(d) Nothing in this subchapter shall be construed to apply to those operating pharmacies. (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.)

§ 2542. Applications and fees for permits.

(a) The application for a permit required under § 2525 of this title shall be made on the form to be prescribed and furnished by the Board and shall be accompanied by a fee of $200.

(b) Separate applications shall be made and separate permits issued for each separate place of manufacture, making, production and packing, packaging, preparation or distribution on a wholesale basis to persons other than the ultimate consumer.

(c) Applicants must meet the minimum requirements for persons engaged in the wholesale distribution of drugs mandated by 21 C.F.R. Chapter I, Subchapter C, Part 205. (Code 1935, § 956B; 41 Del. Laws, c. 87, § 3; 24 Del. C. 1953, § 2572; 53 Del. Laws, c. 90, § 29; 53 Del. Laws, c. 108, § 28; 59 Del. Laws, c. 318, §§ 7, 8; 62 Del. Laws, c. 251, § 18; 68 Del. Laws, c. 206, § 1.)

§ 2543. Permits; display; transfer; term.

Permits issued under the provisions of this subchapter shall:

(1) Be displayed in a conspicuous place in the laboratory or place for which issued;

(2) Not be transferable;

(3) Expire on December 31 biennially. (Code 1935, § 956B; 41 Del. Laws, c. 87, § 3; 24 Del. C. 1953, § 2573; 53 Del. Laws, c. 90, § 30; 62 Del. Laws, c. 251, §§ 19, 20; 68 Del. Laws, c. 206, § 1.)

§ 2544. Inspections.

(a) The Board and its duly authorized agents and representatives and the Department of Health and Social Services and its duly authorized agents and representatives may inspect in a lawful manner the medicines or drugs or drug products or domestic remedies which are manufactured, packed, packaged, made, sold, distributed, dispensed, offered for sale, exposed for sale or kept for sale in the State and for this purpose may enter and inspect during business hours any pharmacy or other place in this State where medicines or drugs or drug products or domestic remedies are manufactured, packed, packaged, made, distributed, dispensed, sold, offered for sale, exposed for sale or kept for sale.

(b) Authorized agents of the Board may inspect and copy records required to be kept by this chapter; inspect within reasonable limits and in a reasonable manner, premises and all pertinent equipment, finished and unfinished material, containers and labeling found therein; all other things therein, including records, files, papers processes, controls and facilities bearing on a violation of this chapter and inventory any stock of medications therein and obtain samples thereof. (Code 1935, § 956D; 41 Del. Laws, c. 87, § 5; 24 Del. C. 1953, § 2574; 68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 149, § 215.)

§ 2545. Hearings.

Any person aggrieved by any Board decision, rule or regulation promulgated by the Board under this subchapter shall be entitled to have the person's complaint set down for hearing by the Board. Requests for such hearings shall be made in writing and shall specify in detail the basis for the complaint. The hearing shall be conducted in accordance with the Administrative Procedures Act, Chapter 101 of Title 29. (Code 1935, § 956B; 41 Del. Laws, c. 87, § 3; 24 Del. C. 1953, § 2575; 68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 186, § 1.)

§ 2546. Appeals to Superior Court.

Any person aggrieved by an order of the Board may appeal therefrom to the Superior Court in the county where such person resided within 30 days after receipt of such order. If the hearing is held in absentia, the order must be appealed within 30 days of issuance. The appeal to the Superior Court shall be on the record of the proceedings before the Board. (Code 1935, § 956B; 41 Del. Laws, c. 87, § 3; 24 Del. C. 1953, § 2576; 68 Del. Laws, c. 206, § 1.)

§ 2547. Penalties.

(a) Whoever violates this subchapter, or whoever, being a permittee under this subchapter, violates any of the conditions of the permit or any of the rules or regulations adopted by the Board in pursuance of its power shall be fined not more than $50 for each offense. Each day such violation continues shall constitute a separate and distinct violation.

(b) In addition to the penalties set out in subsection (a) of this section, upon conviction of a permittee under this section, or a finding by the Board of a violation of this subchapter or the Prescription Drug Marketing Act [P.L. 100-293], the Board may suspend or revoke the permit. (Code 1935, § 956B; 41 Del. Laws, c. 87, § 3; 24 Del. C. 1953, § 2577; 68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 186, § 1.)