Item 25
approvedApr 7, 2021
Authorize to enter into a memorandum of understanding with the US Food and Drug Administration regarding the distribution of inordinate amounts of compounded human drug products interstate and the appropriate investigation by the OPLC of complaints relating to human drug products compounded in the State of NH and distributed outside such State. This MOU is provided for by section 503A(b)(3)(B)(i) of the Federal Food, Drug and Cosmetic Act (the FD&C Act)(12 U.S.C. 353a), and does not apply to veterinary drug products, biological products subject to licensure under section 351 of the Public Health Service Act (42 U.S.C. 262), and drugs that are compounded by outsourcing facilities under section 503B of the FD&C Act. Effective upon G&C approval until terminated by either party.