Delaware Code Title 24. Professions and Occupations § 2540A. Requirements for issuance of license for manufacturers distributors facilities medical gas distributors

(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:

(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.

(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.

(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 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.

(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 (FDA), 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.

(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.