(1) As used in this section:

Ask a business law question, get an answer ASAP!
Thousands of highly rated, verified business lawyers.
Click here to chat with a lawyer about your rights.

Terms Used In Utah Code 4-2-801

  • Department: means the Department of Agriculture and Food created in Chapter 2, Administration. See Utah Code 4-1-109
  • Process: means a writ or summons issued in the course of a judicial proceeding. See Utah Code 68-3-12.5
  • United States: includes each state, district, and territory of the United States of America. See Utah Code 68-3-12.5
     (1)(a) “Cosmetic” means the same as that term is defined in 21 U.S.C. § 321.
     (1)(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)

     (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:

          (2)(a)(i) the criteria for receiving a good manufacturing practices certificate, including the qualifications for registering with the department as required by Subsection (3)(a);
          (2)(a)(ii) the process to apply for and receive a good manufacturing practices certificate under this section; and
          (2)(a)(iii) criteria by which the department will determine the term of a good manufacturing practices certificate in accordance with Subsection (5).
     (2)(b) Rules made pursuant to this section may not be more stringent than:

          (2)(b)(i) rules established by federal law; or
          (2)(b)(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:

     (3)(a) the applicant is registered with the department pursuant to registration requirements established by the department under Subsection (2)(a);
     (3)(b) the applicant submits an application to the department requesting a certificate for the applicant’s manufacturing facility; and
     (3)(c) the department inspects the applicant’s manufacturing facility and determines that the applicant is in compliance with good manufacturing practices.
(4)

     (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.
     (4)(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:

     (5)(a) specify the certificate issuance date and expiration date; and
     (5)(b) be valid for a term of one to three years as determined by the department pursuant to criteria established under Subsection (2)(a).