Section Ph 1001.01 - License Required(a) No person shall manufacture or act as a wholesale distributor of prescription drugs or prescription devices without first obtaining a license to do so from the board pursuant to this chapter. No license shall be issued or renewed for a manufacturer or wholesale drug distributor unless the same shall be operated in a manner prescribed by law and according to the rules adopted by the board with respect thereto.(b) Separate licenses shall be required for each manufacturing and distribution site owned or operated by a manufacturer or wholesale distributor. Provided however, that an agent or employee of any licensed manufacturer or wholesale distributor shall not be required to be licensed under this section and may lawfully possess prescription drugs and devices if the agency or employee is acting in the usual course of his or her business or employment. (c) All licenses for manufacturers and wholesale distributors of prescription drugs and medical devices containing a prescription drug shall expire biennially on June 30th of every even-numbered year. The renewal application may be obtained from the board office. Alternatively, applicants may file the renewal application online at https://nhlicenses.nh.gov/eGov/Login.aspx.(d) The prescribed fee for original and biennial renewal licenses for manufacturers and wholesale distributors of prescription drugs and devices shall be $500.(e) No in-state license shall be issued until such time as the applicant has satisfactorily completed a site inspection performed by the board confirming the facility: (1) Is of suitable size, construction, and location to allow proper storage, handling and security of drugs;(2) Is located in a commercially zoned area;(3) Has adequate outside lighting to allow for proper security;(4) Has notified the local police department that legend drugs are being stored at the facility; and (5) Has a functioning alarm system in place.N.H. Admin. Code § Ph 1001.01
#8447, INTERIM, eff 10-14-05, EXPIRED: 4-12-06
New. #8708, eff 8-23-06
Amended by Volume XXXVI Number 45, Filed November 10, 2016, Proposed by #12007, Effective 10/22/2016, Expires 10/22/2026.Amended by Volume XL Number 46, Filed November 12, 2020, Proposed by #13117, Effective 10/15/2020, Expires 10/15/2030