Current through Register Vol. 54, No. 17, April 27, 2024
Section 25.113 - Requirements for registration(a) Every person who manufactures, distributes or retails drugs or devices within the Commonwealth or proposes to engage in the manufacture, distribution or retail sale of drugs or devices within the Commonwealth shall obtain annually a registration unless exempted under § 25.114 (relating to persons exempt from registration).(b) Only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing drugs or devices is not required to obtain a registration.)(c) Any manufacturer or distributor of drugs or devices not operating an establishment within the Commonwealth shall either obtain a registration or maintain with the secretary an up-to-date listing of the names and addresses of its representatives operating within the Commonwealth.(d) Separate registration is required for each place where drugs or devices are manufactured or sold. (For example, establishments whose locations are not contiguous are separate places.)(e) Registration as a distributor is required by every person not exempt under the act who sells or otherwise distributes any of the following: (1) Controlled substances.(2) Nonproprietary drugs.(3) Devices which are labeled to require a physician's order.(4) Any drug having a stimulant or depressant effect which is sold or otherwise distributed to one person or address in quantities of a 1000 or more doses within a given 30-day period.(f) The sales described in subsection (e) will be considered to be for resale or redistribution and not for personal use.The provisions of this § 25.113 amended February 5, 1982, effective 3/8/1982, 12 Pa.B. 522.The provisions of this § 25.113 issued under sections 2102(g) and 2108 of The Administrative Code of 1929 (71 P. S. §§ 532(g) and 538).