Current through Pa Acts 2024-53, 2024-56 through 2024-111
Section 780-106 - Registration(a) No person shall operate within this Commonwealth as a manufacturer, distributor or retailer of controlled substances, other drugs and devices nor sell, offer for sale nor solicit the purchase of controlled substances, other drugs and devices nor hold them for sale or resale until such person has registered under this act with the secretary. Such registration must be renewed annually in accordance with rules and regulations relating thereto. (1) Any manufacturer or distributor not operating an establishment within this Commonwealth, but employing sales representatives or agents within this Commonwealth, shall either register as a manufacturer or distributor as the case may be, or file, in lieu of registration, with the secretary the names and addresses of such representatives and agents, and shall promptly inform the secretary of any changes in said list.(2) Separate registration with the secretary shall be required annually for each place at which such person carries on activities as a manufacturer, distributor or retailer within this Commonwealth. The certificate evidencing such registration shall be conspicuously displayed and shall not be transferable.(3) Registrations issued by the secretary or under the law preceding this act to manufacturers, distributors or retailers shall continue to be valid for the period issued and, upon expiration, shall be renewed in the manner provided for renewal of registration issued pursuant to this section. Nothing contained herein shall be construed to require the registration hereunder of any practitioner registered or licensed by the appropriate State board, nor to require the separate registration of agents or employes of persons registered pursuant to the provisions of this section, or of sales representatives or agents of manufacturers or distributors not operating an establishment within this Commonwealth whose names and addresses are on file with the secretary: Provided, however, That all persons registered pursuant to this section, whether located within this Commonwealth or not, shall be deemed to have accepted and shall be subject to all provisions of this act.(b) No person shall operate as a manufacturer of controlled substances or other drugs unless they are manufactured under the supervision of a registered pharmacist, chemist or other person possessing at least five years' experience in the manufacture of controlled substances, or other drugs or such other person approved by the secretary as 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.(c) Each application for registration as a manufacturer, distributor or retailer shall be accompanied by a fee to be set by the secretary. Applications shall be on forms prescribed by the secretary. Registration shall be renewed annually and applications therefor shall be accompanied by the same fee as for initial applications.(d) Initial registration shall become effective at noon on the sixtieth day after application therefor is filed: Provided, however, That the secretary shall have authority to issue a registration or to issue an order denying such registration pursuant to subsection (e) hereof at any time prior to the expiration of such sixty day period. Renewal of registration shall be effective upon certification by the secretary that the applicant has met all requirements for such renewal.(e) The secretary may refuse the initial registration and may, after notice and hearing pursuant to the Administrative Agency Law, suspend registration (i) of any person who has made material false representation in the application for registration; (ii) of any manufacturer or distributor who has been convicted of a violation of any law of this Commonwealth or of the United States relating to controlled substances, if such refusal shall be necessary for the protection of the public health and safety; (iii) of any manufacturer or distributor who knowingly employs in a capacity directly connected with the preparation, handling or sale of controlled substances any person convicted of a violation of the laws of this Commonwealth or of the United States relating to the sale, use or possession of controlled substances, if such refusal shall be necessary for the protection of the public health and safety.(f) If the secretary takes any action refusing registration or revoking or suspending registration under subsections (e) and (f), the aggrieved party may, within fifteen days after the date upon which a copy of the order is delivered to the address indicated on the application or the registration whichever is applicable, petition the board for review. The board shall, within thirty days, grant a hearing and, as soon thereafter as practicable, adopt, modify or reject the action of the secretary. Any action by the board shall be deemed an adjudication to which the provisions of the Administrative Agency Law, as amended, shall be applicable.(g) The following persons need not register and may lawfully possess controlled substances under this act: (1) an agent or employe of any registered manufacturer, distributor, dispenser or any person listed in lieu of registration with the secretary if he is acting in the usual course of his business or employment;(2) a common or contract carrier or warehouseman, or an employe thereof, whose possession of any controlled substance is in the usual course of business or employment;(3) an ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or in lawful possession of a Schedule V substance. 1972, April 14, P.L. 233, No. 64, § 6, eff. 6/14/1972.