TITLE 24
Professions and Occupations
CHAPTER 25. Pharmacy [Effective June 30, 2026].
Subchapter V. Pharmaceutical Establishments Other Than Pharmacies [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person permitted to operate a pharmaceutical establishment by receiving, inventorying, and managing the disposition of outdated or otherwise nonsalable drugs.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.
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;(a) All applicants under this subchapter must meet all of the following requirements:
(1) The establishment must operate under the personal and immediate supervision of a person who meets state and federal requirements.
(2) The establishment has not been disciplined by a regulatory agency. The Board may, after a hearing or review of documentation, determine whether such discipline is grounds to deny licensure.
(3) No member of the key personnel has done any of the following:
a. Obtained a license by misrepresentation or fraud.
b. Attempted to procure, or has procured, a license for any other person by making, or causing to be made, any false representation.
c. Been convicted of a crime substantially related to the practice of pharmacy. The Board may, after a hearing or review of documentation, determine whether such criminal conviction is grounds to deny licensure.
d. Been disciplined by a regulatory agency. The Board may, after a hearing or review of documentation, determine whether such discipline is grounds to deny licensure.
(4) All key personnel must submit fingerprints and other necessary information in order to obtain a report of the individual’s 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 such individuals 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 is the intermediary for the purpose of this subsection and the Board, 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.
(5) The application for a license to operate a pharmaceutical establishment must be accompanied by any application fee or license fee established by the Division. A separate license is required for each location. The license must be available for inspection by authorized persons.
(6) A license to operate a pharmaceutical establishment issued under this subchapter terminates automatically upon the termination of the pharmaceutical establishment’s legal existence or upon the discontinuance of business or professional practice.
(b) Requirements for a manufacturer. —
An applicant for licensure as a manufacturer must meet all of the following requirements:
(1) Provide information about ownership and key personnel, including designated representative and supervisor.
(2) Provide recent good manufacturing practice (GMP) inspection report which is acceptable to the Board.
(3) Provide proof of registration pursuant to 21 U.S.C. § 360, where applicable.
(4) Provide proof of licensure or registration by the state in which the manufacturer is physically located, where applicable.
(5) Meet the applicable requirements set forth in the Board’s rules and regulations.
(c) Requirements for an outsourcing facility. —
An applicant for licensure must meet all of the following requirements:
(1) Provide information about ownership and key personnel, including designated representative and supervisor.
(2) Provide recent GMP inspection report which is acceptable to the Board.
(3) Provide proof of licensure or registration by the state in which the manufacturer is physically located, where applicable.
(4) Meet the applicable requirements set forth in the Board’s rules and regulations.
(d) Requirements for a wholesale distributor. —
(1) Provide information about ownership and key personnel, including designated representative and supervisor.
(2) Provide a set of floor plans for the physical location.
(3) Provide the lease or deed for the physical location.
(4) Provide regulatory letter from the Food and Drug Administration, where applicable.
(5) Provide proof of licensure or registration by the state in which the wholesale distributor is physically located, where applicable.
(6) Meet the applicable requirements set forth in the Board’s rules and regulations.
(e) Requirements for a medical gas dispenser. —
(1) Provide information about ownership and key personnel, including designated representative and supervisor.
(2) Provide a set of floor plans for the physical location.
(3) Provide proof of licensure or registration by the state in which the medical gas distributor is physically located, where applicable.
(4) Meet the applicable requirements set forth in the Board’s rules and regulations.
85 Del. Laws, c. 49, § 1;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.
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; 76 Del. Laws, c. 167, § 1; 85 Del. Laws, c. 49, § 1;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 the Administrative Procedures Act, Chapter 101 of Title 29.
Code 1935, § 956B; 41 Del. Laws, c. 87, § 3; 24 Del. C. 1953, §§ 2575, 2576; 68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 186, § 1; 76 Del. Laws, c. 167, § 1; 85 Del. Laws, c. 49, § 1;Inspections of pharmaceutical establishments are conducted in the same manner as inspections of pharmacies pursuant to § 2534 of this title.
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; 76 Del. Laws, c. 167, § 1; 85 Del. Laws, c. 49, § 1;The Board may discipline a license to operate a pharmaceutical establishment, other than a pharmacy, where:
(1) The establishment is not being operated according to applicable state and federal law and the Board’s rules and regulations.
(2) A member of the key personnel has been convicted of a crime substantially related to the practice of pharmacy.
(3) The establishment or a member of the key personnel has been disciplined by a regulatory agency.
(4) The establishment has obtained a license by misrepresentation or fraud.
(5) The establishment has refused access to the pharmacy or pharmacy records to an agent of the Board who seeks access for the purpose of conducting an inspection or investigation.
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; 76 Del. Laws, c. 167, § 1; 85 Del. Laws, c. 49, § 1;The Board may impose any of the following sanctions, individually or in combination, when it finds that 1 or more of the conditions or violations set forth in § 2545 of this title applies to a pharmaceutical establishment regulated by this subchapter:
(1) Issue a letter of reprimand.
(2) Place an establishment on probationary status and require the establishment to do any of the following:
a. Report regularly to the Board upon matters which are related to the basis of the probation.
b. Limit all practice and professional activities as prescribed by the Board.
(3) Suspend any establishment’s license.
(4) Permanently revoke any establishment’s license.
(5) Impose a monetary penalty not to exceed $250,000 for each violation and not more than $250,000 for each day of a continuing violation.
85 Del. Laws, c. 49, § 1;