Every person who owns or maintains a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States is required under Section 607(a)(1) of the FD&C Act to register each facility, with the following exceptions:
• A facility that is exempt from registration as a "small business" as described in section III.A. above;
• A facility that is also subject to the requirements in Chapter V of the FD&C Act (for drugs and devices) unless the facility also manufactures or processes cosmetic products that are not subject to the requirements of Chapter V of the FD&C Act (see Section 613 of the FD&C Act).
According to Section 607(a)(3) of the FD&C Act, even if a facility manufactures or processes its own cosmetic products or cosmetic products on behalf of more than one responsible person, only a single registration is necessary for that facility if it does so on behalf of a responsible person (i.e., a contract manufacturer). The facility registration for such a facility may be submitted by a responsible person whose goods are produced at the facility. According to this method, if the appropriate party raised the issue of facility registration, neither the owner nor the operator of a contract manufacturing facility would register the facility.
The responsible person is required to file a cosmetic product listing for each cosmetic product under Section 607(c) of the FD&C Act, with the following exceptions:
• The responsible person that is exempt as a "small business" as described in section III.A. above;
• The cosmetic product is also subject to the requirements in Chapter V of the FD&C Act (for drugs and devices). For example, if the product is both a drug and a cosmetic product under the FD&C Act, a cosmetic product listing must not be submitted for such a product (see Section 613 of the FD&C Act).