United States · regulation · 21 CFR · 8,317 active provisions
(a) The provisions of regulations promulgated under the Federal Food, Drug, and Cosmetic Act with respect to the doing of any act shall be applicable also to the causing of such act to be done. (b) The definitions and interpretations of terms contained in sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act…
(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) Label means any display of written, printed, or graphic matter on the immediate container of any article,…
(a) For each part of its regulations, the Food and Drug Administration includes a centralized citation of all of the statutory provisions that provide authority for any regulation that is included in that part. (b) The agency may rely on any one or more of the authorities that are listed for a particular part in implem…
In the regulations specified in § 1.1(c) of this chapter, the term package means any container or wrapping in which any food, drug, device, or cosmetic is enclosed for use in the delivery or display of such commodities to retail purchasers, but does not include: (a) Shipping containers or wrappings used solely for the…
(a) Labeling of a food, drug, device, cosmetic, or tobacco product shall be deemed to be misleading if it fails to reveal facts that are: (1) Material in light of other representations made or suggested by statement, word, design, device or any combination thereof; or (2) Material with respect to consequences which may…
Section 403(e) of the act (in this part 1, the term act means the Federal Food, Drug, and Cosmetic Act) provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 403(i) of the act provides for the establishm…
The following exemptions are granted from label statements required by this part: (a) Foods. (1) While held for sale, a food shall be exempt from the required declaration of net quantity of contents specified in this part if said food is received in bulk containers at a retail establishment and is accurately weighed, m…
This subpart specifies the data elements that are required by the Food and Drug Administration (FDA) to be included in an electronic import entry submitted in the Automated Commercial Environment (ACE) system or any other U.S. Customs and Border Protection (CBP)-authorized electronic data interchange (EDI) system, whic…
For purposes of subpart D: ACE filer means the person who is authorized to submit an electronic import entry for an FDA-regulated product in the Automated Commercial Environment or any other CBP-authorized EDI system. Acidified food means acidified food, as defined in § 114.3(b) of this chapter, and subject to the requ…
General. When filing an entry in ACE, the ACE filer shall submit the following information for food contact substances, drugs, biological products, HCT/Ps, medical devices, veterinary devices, radiation-emitting electronic products, cosmetics, and tobacco products. (a) Product identifying information for the article th…
(a) Food contact substances. An ACE filer must submit the information specified in § 1.72 at the time of filing entry in ACE for food that is a food contact substance. (b) Low-acid canned food. For an article of food that is a low-acid canned food, the ACE filer must submit at the time of filing entry the Food Canning…
In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for drugs, including biological products and eligible prescription drugs as defined in § 251.2 of this chapter that are imported or offered for import under section 804 of th…
(a) Animal drugs. In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for animal drugs: (1) Registration and listing. For a drug intended for animal use, the Drug Registration Number and the Drug Listing Number if the foreign…
In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for medical devices regulated by the FDA Center for Devices and Radiological Health. (a) Registration and listing. For a medical device, the Registration Number for Foreign M…
In addition to the data required to be submitted in § 1.72, an ACE filer must submit all of the declarations required in Form FDA 2877 electronically in ACE at the time of filing entry for products subject to the standards under parts 1020-1050 of this chapter.
In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for biological products, HCT/Ps, and related drugs and medical devices regulated by the FDA Center for Biologics Evaluation and Research. (a) Product name which identifies th…
In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE. (a) Brand name of an article that is a tobacco product that is being imported or offered for import. If the article does not have a specific brand name, the ACE filer must s…
An ACE filer must submit the data specified in § 1.72 at the time of filing entry in ACE.
FDA may reject an entry filing for failure to provide complete and accurate information that is required pursuant to this subpart.
For the purposes of regulations prescribed under section 801(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act: (a) The term owner or consignee means the person who makes entry under the provisions of section 484 of the Tariff Act of 1930, as amended (19 U.S.C. 1484), namely, the “importer of record.” (b) Th…
When a sample of an article offered for import has been requested by the division director, FDA shall provide to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or consignee shall hold such article and not distribute it until further notic…
The Food and Drug Administration will pay for all import samples which are found to be in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. Billing for reimbursement should be made by the owner or consignee to the Food and Drug Administration division where the shipment was offered for impor…
(a) If it appears that the article may be subject to refusal of admission or that the article is a drug or device that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the division director shall give the owner or consignee a written or electronic notice to that effect, st…
Application for authorization to relabel or perform other action to bring the article into compliance with the Federal Food, Drug, and Cosmetic Act or to render it other than a food, drug, device, or cosmetic may be filed only by the owner or consignee, and shall: (a) Contain detailed proposals for bringing the article…
(a) When authorization of a proposal under § 1.95 is granted by the division director, the applicant shall be notified of authorization, in writing, which may include: (1) The procedure to be followed; (2) The disposition of the rejected articles or portions thereof; (3) That the operations are to be carried out under…