4-2-801. Good manufacturing practices for cosmetics.

365 words·~2 min read·/ut/title-4/chapter-2/4-2-801

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Effective 5/4/2022

(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.

(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.

(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