4-2-801. Good manufacturing practices for cosmetics.
| (1) |
As used in this section:
Terms Used In Utah Code 4-2-801
| (a) |
“Cosmetic” means the same as that term is defined in 21 U.S.C. § 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. |
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| (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). |
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| (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. |
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| (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. |
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| (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. |
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| (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). |
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Enacted by Chapter 268, 2022 General Session
