21 U.S.C. § 364c Registration and Product Listing

• Library: United States Statutes
• Edition: 2023 Edition
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)

(a) Submission of registration

(1) Initial registration

(A) Existing facilities

Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.

(B) New facilities

Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.

(2) Biennial renewal of registration

A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.

(3) Contract manufacturers

If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.

(4) Updates to content

A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under subsection (b)(2).

(5) Abbreviated renewal registrations

The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registration of such facility under paragraph (1) or (2).

(b) Format; contents of registration

(1) In general

Registration information under this section may be submitted at such time and in such manner as the Secretary may prescribe.

(2) Contents

The registration under subsection (a) shall contain-

(A) the facility's name, physical address, email address, and telephone number;

(B) with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information;

(C) the facility registration number, if any, previously assigned by the Secretary under subsection (d);