N.M. Admin. Code § 16.19.37.8

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.19.37.8 - LICENSURE OR REGISTRATION

A. Any outsourcing facility that is engaged in the compounding of sterile drugs in this state shall be registered as an outsourcing facility under the Federal Food, Drug, and Cosmetic Act and be licensed as an outsourcing facility in this state.

B. Any nonresident outsourcing facility, that distributes or causes to be distributed, compounded sterile drugs into New Mexico shall be registered as an outsourcing facility under the Federal Food, Drug, and Cosmetic Act and be licensed as a nonresident outsourcing facility.

C. No outsourcing facility shall ship, mail or deliver controlled substances in or into this state unless registered by the Drug Enforcement Administration (DEA) and the board for controlled substances.

D. Applications for a nonresident outsourcing facility under this section shall be made on a form furnished by the board. The board may require such information as it deems is reasonably necessary to carry out the purposes of this section.

E. The board shall not issue an initial or renewed license for an outsourcing facility unless the facility furnishes the board with a report, issued by the appropriate regulatory agency of the resident state, or entity approved by the appropriate regulatory agency of the resident state, or by the FDA, of an inspection that has occurred within the 12 months immediately preceding receipt of the license application by the board (with no intervening change in outsourcing facility ownership). The board may deny licensure unless the applicant submits documentation satisfactory to the board that any defciencies noted in an inspection report have been corrected.

F. No license shall be issued or renewed for an outsourcing facility unless the applicant supplies the board with proof of such registration by the FDA.

G. No license shall be issued or renewed for a non-resident outsourcing facility that is required to be licensed or registered by the state in which it is physically located unless the applicant supplies the board with proof of such licensure or registration. The board may establish, by rule, standards for the licensure of an outsourcing facility that is not required to be licensed or registered by the state in which it is physically located.

H. The license fee shall be as specified in 16.19.12 NMAC, and shall be renewed biennially before the last day of December each year.

I. The board may deny, revoke or suspend an outsourcing facility's registration for any violation of the state drug laws.

N.M. Admin. Code § 16.19.37.8

Adopted by New Mexico Register, Volume XXVI, Issue 22, November 30, 2015, eff. 12/13/2015