CFR Part 710

CFR Part 710
in effect

21 C.F.R. § 710.1 Who should register.

The owner or operator of a cosmetic product establishment which is not exempt under § 710.9 and engages in the manufacture or packaging of a cosmetic product is requested to register for each such establishment, whether or not the product enters interstate commerce. This request extends to any foreign cosmetic product establishment whose products are exported for sale in any State as defined in section 201(a)(1) of the act. No registration fee is required.

21 C.F.R. § 710.2 Time for registration.

The owner or operator of an establishment entering into the manufacture or packaging of a cosmetic product should register his establishment within 30 days after the operation begins.

21 C.F.R. § 710.3 How and where to register.

Form FD-2511 (“Registration of Cosmetic Product Establishment”) is obtainable on request from the Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at any Food and Drug Administration district office. The completed form should be mailed to Cosmetic Product Establishment Registration, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

21 C.F.R. § 710.4 Information requested.

Form FD-2511 requests information on the name and address of the cosmetic product establishment, including post office ZIP code; all business trading names used by the establishment; and the type of business (manufacturer and/or packer). The information requested should be given separately for each establishment as defined in § 700.3(j) of this chapter.

21 C.F.R. § 710.5 Amendments to registration.

Within 30 days after a change in any of the information contained on a submitted Form FD-2511, a new Form FD-2511 should be submitted to amend the registration. This amendment is also necessary when a registration is to be canceled because an establishment has changed its name and no longer conducts business under the original name.

21 C.F.R. § 710.6 Notification of registrant; cosmetic product establishment registration number.

The Commissioner of Food and Drugs will provide the registrant with a validated copy of Form FD-2511 as evidence of registration. This validated copy will be sent only to the location shown for the registering establishment. A permanent registration number will be assigned to each cosmetic product establishment registered in accordance with the regulations in this part.

21 C.F.R. § 710.7 Inspection of registrations.

A copy of the Form FD-2511 filed by the registrant will be available for inspection at the Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

21 C.F.R. § 710.8 Misbranding by reference to registration or to registration number.

Registration of a cosmetic product establishment or assignment of a registration number does not in any way denote approval of the firm or its products by the Food and Drug Administration. Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number will be considered misleading.

21 C.F.R. § 710.9 Exemptions.

The following classes of persons are not requested to register in accordance with this part 710 because the Commissioner has found that such registration is not justified: (a) Beauty shops, cosmetologists, retailers, pharmacies, and other persons and organizations that compound cosmetic products at a single location and administer, dispense, or distribute them at retail from that location and who do not otherwise manufacture or package cosmetic products at that location. (b) Physicians, hospitals, clinics, and public health agencies. (c) Persons who manufacture, prepare, compound, or process cosmetic products solely for use in research, pilot plant production, teaching, or chemical analysis, and who do not sell these products.

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