Section 801 – Good manufacturing practices for cosmetics.

• (1) As used in this section:
  • (a) “Cosmetic” means the same as that term is defined in 21 U.S.C. Sec. 321.
  • (b) “Good manufacturing practices” means the current good manufacturing practices described in the United States Food and Drug Administration’s Guidance for Industry: Cosmetic Good Manufacturing Practices.

• (2)
  • (a) In accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, and consistent with this section, the department shall make and enforce rules establishing a voluntary certification program for good manufacturing practices for cosmetics, including:
    • (i) the criteria for receiving a good manufacturing practices certificate, including the qualifications for registering with the department as required by Subsection (3)(a);
    • (ii) the process to apply for and receive a good manufacturing practices certificate under this section; and
    • (iii) criteria by which the department will determine the term of a good manufacturing practices certificate in accordance with Subsection (5).
  • (b) Rules made pursuant to this section may not be more stringent than:
    • (i) rules established by federal law; or
    • (ii) guidance published by the United States Food and Drug Administration.

• (3) The department’s good manufacturing practices certification program shall provide for the issuance of a certificate to an applicant if:
  • (a) the applicant is registered with the department pursuant to registration requirements established by the department under Subsection (2)(a);
  • (b) the applicant submits an application to the department requesting a certificate for the applicant’s manufacturing facility; and
  • (c) the department inspects the applicant’s manufacturing facility and determines that the applicant is in compliance with good manufacturing practices.

• (4)
  • (a) In accordance with Section 63J-1-504, the department shall adopt a schedule of registration and certificate fees to cover the department’s costs of administering the certification program described in this section.
  • (b) Notwithstanding Section 63J-1-504, the department shall retain the fees as dedicated credits.

• (5) A good manufacturing practices certificate issued under this section shall:
  • (a) specify the certificate issuance date and expiration date; and
  • (b) be valid for a term of one to three years as determined by the department pursuant to criteria established under Subsection (2)(a).

Enacted by Chapter 268, 2022 General Session