§ 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person permitted to operate a pharmaceutical establishment by receiving, inventorying, and managing the disposition of outdated or otherwise nonsalable drugs.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.
§ 2541 Application and fee for a permit to operate a pharmaceutical establishment.
(a) The application for a permit to operate a pharmaceutical establishment must be made on a form furnished by the Board and must be accompanied by an application fee and/or permit fee established pursuant to § 2511 of this title. A separate permit is required for each location. The permit must be available for inspection by authorized persons. The Executive Secretary, jointly with the Board president, may issue a temporary, 60-day permit to operate an otherwise qualified pharmaceutical establishment while the application for a permanent permit is pending. The Board may grant 1 60-day extension of a temporary permit.
(b) An applicant may not be licensed until its key personnel submit fingerprints and other necessary information in order to obtain a report of the individuals' entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C § 534). If the applicant's key personnel do not have a criminal history record, the applicant shall cause to be submitted a statement from each agency that the agency has no record of criminal history information relating to the individual. The State Bureau of Identification shall be the intermediary for the purpose of this subsection and the Board of Pharmacy, or its designee, shall be the screening point for the receipt of the federal criminal history record. The applicant is responsible for the required fee, if any, for obtaining the records.
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; 76 Del. Laws, c. 167, § 1; 79 Del. Laws, c. 277, § 14.;
§ 2542 Renewal of permit.
A permit to operate a pharmaceutical establishment must be renewed biennially in a manner determined by the Division, including the payment of the renewal fee established pursuant to § 2511 of this title.
§ 2543 Hearings and appeals to Superior Court.
A person aggrieved by a Board decision made pursuant to this subchapter has the substantive and procedural rights to notice, hearing, and appeal described in § 2531 of this title.
§ 2544 Inspections.
Inspections of pharmaceutical establishments are conducted in the same manner as inspections of pharmacies pursuant to § 2534 of this title and, in addition, include the inspection of and activities related to toilet preparations, dentifrices, and cosmetics.
§ 2545 Penalties.
(a) The Board may suspend or revoke a permit to operate a pharmaceutical establishment if the permit holder violates federal law or any state's law, any of the conditions of the permit, or any of the rules or regulations adopted by the Board relating to the operation of a pharmaceutical establishment. The Board may impose an administrative penalty of not more than $50 for each day a violation occurs and/or continues to occur.
(b) A person who commits the offense of operating a pharmaceutical establishment without a permit may be fined not more than $50 for each day that the offense occurs and/or continues to occur.