Title 21 CFR reference

(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 (21 U.S.C. 321 and 387) shall be applicable also to such terms when used in regulations promulgated under that act. packageprincipal display panel(c) The definition of in § 1.20 and of in §§ 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter; and the requirements pertaining to uniform location, lack of qualification, and separation of the net quantity declaration in §§ 101.7(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this chapter to type size requirements for net quantity declaration in §§ 101.7(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this chapter, to initial statement of ounces in the dual declaration of net quantity in §§ 101.7(j) and (m), 201.62(i) and (k), 501.105(j) and (m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial statement of inches in declaration of net quantity in §§ 201.62(m), 701.13(o) and…

Scope.(a) This section pertains to notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262). Recordkeeping requirements for human drugs, biological products, devices, animal drugs, foods, cosmetics, and tobacco products exported under or subject to section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.(b) Persons exporting an article under section 801(e)(1) of the act or an article otherwise subject to section 801(e)(1) of the act shall maintain records as enumerated in paragraphs (b)(1) through (b)(4) of this section demonstrating that the product meets the requirements of section 801(e)(1) of the act. Such records shall be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product, except that records pertaining to the export of foods and cosmetics under section 801(e)(1) of the act shall be kept for 3 years after the date of…

packageIn the regulations specified in § 1.1(c) of this chapter, the term 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 transportation of any such commodity in bulk or in quantity to manufacturers, packers, processors, or wholesale or retail distributors; (b) Shipping containers or outer wrappings used by retailers to ship or deliver any such commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity; or (c) Containers subject to the provisions of the Act of August 3, 1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), the Act of March 4, 1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August 31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i). (d) Containers used for tray pack displays in retail establishments. (e) Transparent wrappers or containers which do not bear written, printed, or graphic matter obscuring the label…

(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 result from use of the article under: (i) The conditions prescribed in such labeling or (ii) such conditions of use as are customary or usual. (b) Affirmative disclosure of material facts pursuant to paragraph (a) of this section may be required, among other appropriate regulatory procedures, by (1) Regulations in this chapter promulgated pursuant to section 701(a) of the act; or (2) Direct court enforcement action. (c) Paragraph (a) of this section does not: (1) Permit a statement of differences of opinion with respect to warnings (including contraindications, precautions, adverse reactions, and other information relating to possible product hazards) required in labeling for food, drugs, devices, cosmetics, or tobacco products under the Federal Food, Drug, and Cosmetic Act. (2) Permit a statement of differences of opinion with respect to the effectiveness…

actSection 403(e) of the act (in this part 1, the term 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 establishment by regulation of exemptions from the required declaration of ingredients where such declaration is impracticable, or results in deception or unfair competition. Section 502(b) of the 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 602(b) of the 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 5(b) of the Fair Packaging and Labeling Act provides for the establishment by regulation of exemptions from certain required declarations of net quantity of contents, identity of commodity, identity and location of manufacturer, packer, or distributor, and from declaration of net quantity of servings represented, based on a…

The following exemptions are granted from label statements required by this part: Foods.(a) (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, measured, or counted either within the view of the purchaser or in compliance with the purchaser's order. (2) Random food packages, as defined in § 101.7(j) of this chapter, bearing labels declaring net weight, price per pound or per specified number of pounds, and total price shall be exempt from the type size, dual declaration, and placement requirements of § 101.7 of this chapter if the accurate statement of net weight is presented conspicuously on the principal display panel of the package. In the case of food packed in random packages at one place for subsequent shipment and sale at another, the price sections of the label may be left blank provided they are filled in by the seller prior to retail sale. This exemption shall also apply to uniform weight packages of cheese and cheese products labeled in the same manner and by the same type of equipment as random…

Labeling(a) 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. Label(b) means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.

(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 implementing or enforcing any section in that part. (c) All citations of authority in this chapter will list the applicable sections in the organic statute if the statute is the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair Packaging and Labeling Act. References to an act or a section thereof include references to amendments to that act or section. These citations will also list the corresponding United States Code (U.S.C.) sections. For example, a citation to section 701 of the Federal Food, Drug, and Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371). (d) If the organic statute is one other than those specified in paragraph (c) of this section, the citations of authority in this chapter generally will list only the applicable U.S.C. sections. For example, a citation to section 552 of…

The following definitions apply to words and phrases as they are used in this subpart. Other definitions of these terms may apply when they are used in other subparts of this part. Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice. Audit means the systematic, independent, and documented examination (through observation, investigation, discussions with employees of the audited entity, records review, and, as appropriate, sampling and laboratory analysis) to assess an audited entity's food safety processes and procedures. Dietary supplement has the meaning given in section 201(ff) of the Federal Food, Drug, and Cosmetic Act. Dietary supplement component means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Dietary supplement components include dietary ingredients (as described in section 201(ff) of the Federal Food, Drug, and Cosmetic Act) and other ingredients. Environmental pathogenListeria monocytogenesSalmonella means a pathogen capable of surviving and persisting within the manufacturing,…

General.(a) Except as specified otherwise in this section, the requirements in this subpart apply to all food imported or offered for import into the United States and to the importers of such food. Exemptions for juice and seafoodImporters of certain juice and seafood products.(b) —(1) This subpart does not apply with respect to juice, fish, and fishery products that are imported from a foreign supplier that is required to comply with, and is in compliance with, the requirements in part 120 or part 123 of this chapter. If you import juice or fish and fishery products that are subject to part 120 or part 123, respectively, you must comply with the requirements applicable to importers of those products under § 120.14 or § 123.12 of this chapter, respectively. Certain importers of juice or seafood raw materials or other ingredients subject to part 120 or part 123 of this chapter.(2) This subpart does not apply with respect to any raw materials or other ingredients that you import and use in manufacturing or processing juice subject to part 120 or fish and fishery products subject to part 123, provided that you are in compliance with the requirements in part 120 or part 123 with…

General.(a) Except as specified in paragraph (b) of this section, for each food you import, you must develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (regarding standards for produce safety), if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (if applicable) (regarding misbranding with respect to labeling for the presence of major food allergens) of the Federal Food, Drug, and Cosmetic Act. Low-acid canned foodsImporters of low-acid canned foods not subject to further manufacturing or processing.(b) —(1) With respect to those microbiological hazards that are controlled by part 113 of this chapter, if you import a thermally processed low-acid food packaged in a hermetically sealed container (low-acid canned food), you must verify and document that the food was produced in…

Qualified individual.(a) A qualified individual must develop your FSVP and perform each of the activities required under this subpart. A qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an activity. Qualified auditor.(b) A qualified auditor must conduct any audit conducted in accordance with § 1.506(e)(1)(i) or § 1.511(c)(5)(i)(A). A qualified auditor must have technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function.

Requirement for a hazard analysis.(a) Except as specified in paragraph (d) of this section, you must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control. Your hazard analysis must be written regardless of its outcome. Hazard identification.(b) (1) Your analysis of the known or reasonably foreseeable hazards in each food must include the following types of hazards: (i) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens; (ii) Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, food allergens, and (in animal food) nutrient deficiencies or toxicities; and (iii) Physical hazards (such as stones, glass, and metal fragments). (2) Your analysis must include known or reasonably foreseeable hazards that may be present in a food for any of the following reasons: (i) The hazard occurs naturally; (ii) The hazard may be…

Evaluation of a foreign supplier's performance and the risk posed by a food.(a) (1) Except as specified in paragraphs (d) and (e) of this section, in approving your foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food you import, you must consider the following: (i) The hazard analysis of the food conducted in accordance with § 1.504, including the nature of the hazard requiring a control. (ii) The entity or entities that will be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, such as the foreign supplier, the foreign supplier's raw material or other ingredient supplier, or another entity in your supply chain. (iii) Foreign supplier performance, including: (A) The foreign supplier's procedures, processes, and practices related to the safety of the food; (B) Applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other…

Use of approved foreign suppliers.(a) (1) You must establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under § 1.505 (or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to adequate verification activities before importing the food). You must document your use of these procedures. (2) You may rely on an entity other than your foreign supplier to establish the procedures and perform and document the activities required under paragraph (a)(1) of this section provided that you review and assess that entity's documentation of the procedures and activities, and you document your review and assessment. Foreign supplier verification procedures.(b) You must establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import. Requirement of supplier verification.(c) The foreign supplier verification activities must provide assurance that the hazards requiring a control in the food you import have been significantly minimized…

Circumstances.(a) You are not required to conduct an evaluation of a food and foreign supplier under § 1.505 or supplier verification activities under § 1.506 when you identify a hazard requiring a control (identified hazard) in a food and any of the following circumstances apply: e.g.,(1) You determine and document that the type of food ( raw agricultural commodities such as cocoa beans and coffee beans) could not be consumed without application of an appropriate control; (2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of part 117 or subpart C of part 507 of this chapter to ensure that the identified hazard will be significantly minimized or prevented and you: (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and (ii) Annually obtain from your customer written assurance, subject to the requirements of paragraph (c) of this section, that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the…

(a) You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the verification activities conducted under § 1.506 or § 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under § 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with…

(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection. (b) Before an article of food is imported or offered for import into the United States, the foreign owner or consignee of the food (if there is no U.S. owner or consignee) must designate a U.S. agent or representative as the importer of the food for the purposes of the definition of “importer” in § 1.500.

General requirements for records.(a) (1) You must keep records as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records. (2) You must sign and date records concerning your FSVP upon initial completion and upon any modification of the FSVP. (3) All records must be legible and stored to prevent deterioration or loss. Record availability.(b) (1) You must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English. (2) Offsite storage of records, including records maintained by other entities in accordance with § 1.504, § 1.505, or § 1.506, is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location. (3) If requested in writing by FDA, you must send records to the Agency electronically, or…

Importers subject to certain requirements in the dietary supplement current good manufacturing practice regulation.(a) If you are required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you import for further manufacturing, processing, or packaging as a dietary supplement, and you are in compliance with the requirements in §§ 111.73 and 111.75 of this chapter applicable to determining whether the specifications you established are met for such food, then for that food you must comply with the requirements in §§ 1.503 and 1.509, but you are not required to comply with the requirements in § 1.502, §§ 1.504 through 1.508, or § 1.510. This requirement does not limit your obligations with respect to part 111 of this chapter or any other laws enforced by FDA. Importers whose customer is subject to certain requirements in the dietary supplement current good manufacturing practice regulation.(b) If your customer is required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you…

Eligibility.(a) This section applies only if: (1) You are a very small importer; or (2) You are importing certain food from certain small foreign suppliers as follows: (i) The foreign supplier is a qualified facility as defined by § 117.3 or § 507.3 of this chapter; (ii) You are importing produce from a foreign supplier that is a farm that grows produce and is not a covered farm under part 112 of this chapter in accordance with § 112.4(a) of this chapter, or in accordance with §§ 112.4(b) and 112.5 of this chapter; or (iii) You are importing shell eggs from a foreign supplier that is not subject to the requirements of part 118 of this chapter because it has fewer than 3,000 laying hens. Applicable requirementsDocumentation of eligibilityVery small importer status.(b) —(1) —(i) (A) If you are a very small importer and you choose to comply with the requirements in this section, you must document that you meet the definition of very small importer in § 1.500 with respect to human food and/or animal food before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year. (B) For the purpose of determining whether you…

General.(a) (1) If you meet the conditions and requirements of paragraph (b) of this section for a food of the type specified in paragraph (a)(2) of this section that you are importing, then you are not required to comply with the requirements in §§ 1.504 through 1.508. You would still be required to comply with the requirements in §§ 1.503, 1.509, and 1.510. (2) This section applies to food that is not intended for further manufacturing/processing, including packaged food products and raw agricultural commodities that will not be commercially processed further before consumption. Conditions and requirements.(b) (1) Before importing a food from the foreign supplier and annually thereafter, you must document that the foreign supplier is in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and that the food is within the scope of that official recognition or equivalency determination. (2) Before importing a food from the foreign supplier, you must determine and document whether the foreign supplier of the food is in good compliance standing with the…

Refusal of admission.(a) An article of food is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act if it appears that the importer of that food fails to comply with this subpart with respect to that food. If there is no U.S. owner or consignee of an article of food at the time the food is offered for entry into the United States, the article of food may not be imported into the United States unless the foreign owner or consignee has appropriately designated a U.S. agent or representative as the importer in accordance with § 1.500. Prohibited act.(b) The importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act, including the requirements of this subpart, is prohibited under section 301(zz) of the Federal Food, Drug, and Cosmetic Act.

FD&C Act(a) The means the Federal Food, Drug, and Cosmetic Act. (b) Except as otherwise defined in paragraph (c) of this section, the definitions of terms in section 201 of the FD&C Act apply when the terms are used in this subpart. (c) In addition, for the purposes of this subpart: Accreditation means a determination by a recognized accreditation body (or, in the case of direct accreditation, by FDA) that a third-party certification body meets the applicable requirements of this subpart. Accreditation body means an authority that performs accreditation of third-party certification bodies. Accredited third-party certification body means a third-party certification body that a recognized accreditation body (or, in the case of direct accreditation, FDA) has determined meets the applicable requirements of this subpart and is accredited to conduct food safety audits and to issue food or facility certifications to eligible entities. An accredited third-party certification body has the same meaning as accredited third-party auditor as defined in section 808(a)(4) of the FD&C Act. Assessment means: (i) With respect to an accreditation body, an evaluation by FDA of the competency…

Accreditation bodies.(a) Any accreditation body seeking recognition from FDA to accredit third-party certification bodies to conduct food safety audits and to issue food and facility certifications under this subpart. Third-party certification bodies.(b) Any third-party certification body seeking accreditation from a recognized accreditation body or direct accreditation by FDA for: (1) Conducting food safety audits; and (2) Issuing certifications that may be used in satisfying a condition of admissibility of an article of food under section 801(q) of the FD&C Act; or issuing a facility certification for meeting the eligibility requirements for the Voluntary Qualified Importer Program under section 806 of the FD&C Act. Eligible entities.(c) Any eligible entity seeking a food safety audit or a food or facility certification from an accredited third-party certification body under this subpart. Limited exemptions from section 801(q) of the FD&C ActAlcoholic beverages.(d) —(1) (i) Any certification required under section 801(q) of the FD&C Act does not apply with respect to alcoholic beverages from an eligible entity that is a facility that meets the following two conditions: et…

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, which contains an article that is being imported or offered for import into the United States and that is regulated by FDA.

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 requirements in parts 108 and 114 of this chapter. Automated Commercial EnvironmentACE or means the automated and electronic system for processing commercial importations that is operated by U.S. Customs and Border Protection in accordance with the National Customs Automation Program established in Subtitle B of Title VI—Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 1993) (Customs Modernization Act), or any other CBP-authorized EDI system. Biological product means a biological product as defined in section 351(i)(1) of the Public Health Service Act. Cosmetic means a cosmetic as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act. CBP or U.S. Customs and Border Protection means the Federal Agency that is primarily responsible for maintaining the integrity of…

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. Product identifying information(a) for the article that is being imported or offered for import. This consists of: FDA Country of Production,(1) which is the country where the article was last manufactured, processed, or grown (including harvested, or collected and readied for shipment to the United States). The FDA Country of Production for an article that has undergone any manufacturing or processing is the country where that activity occurred provided that the manufacturing or processing had more than a minor, negligible, or insignificant effect on the article. The Complete FDA Product Code,(2) which must be consistent with the invoice description of the product. The Full Intended Use Code.(3) Importer of record contact information,(b) which is the telephone and email address of the importer of record. [81 FR 85870, Nov. 29, 2016, as amended at 87 FR 62984, Oct. 18, 2022]

Food contact substances.(a) 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. Low-acid canned food.(b) 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 Establishment Number and the Submission Identifier, and can dimensions or volume, except that the ACE filer does not need to submit this information in ACE at the time of entry if the article is being imported or offered for import for laboratory analysis only and will not be taste tested or otherwise ingested. Acidified food.(c) For an article of food that is an acidified food, the ACE filer must submit at the time of filing entry the Food Canning Establishment Number and the Submission Identifier, and can dimensions or volume, except that the ACE filer does not need to submit this information in ACE at the time of entry if the article is being imported or offered for import for laboratory analysis only and will not be taste tested or otherwise ingested.

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 the Federal Food, Drug, and Cosmetic Act, intended for human use that are regulated by the FDA Center for Drug Evaluation and Research. (a) For a drug intended for human use that is not an eligible prescription drug covered under paragraph (b) of this section: Registration and listing.(1) The Drug Registration Number and the Drug Listing Number of the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States is required to register and list the drug under part 207 of this chapter. For the purposes of this section, the Drug Registration Number that must be submitted at the time of entry filing in ACE is the unique facility identifier of the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before…

Animal drugs.(a) 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: Registration and listing.(1) For a drug intended for animal use, the Drug Registration Number and the Drug Listing Number if the foreign establishment where the drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States is required to register and list the drug under part 207 of this chapter. For the purposes of this section, the Drug Registration Number that must be submitted in ACE at the time of entry is the Unique Facility Identifier of the foreign establishment where the animal drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States. The Unique Facility Identifier is the identifier submitted by a registrant in accordance with the system specified under section 510(b) of the Federal Food, Drug, and Cosmetic Act. For the purposes of this section, the Drug Listing Number is the National Drug Code number of the animal drug article being imported…

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. Registration and listing.(a) For a medical device, the Registration Number for Foreign Manufacturers, Foreign Exporters, and/or Domestic Manufacturers, and the Device Listing Number, required under section 510 of the Federal Food, Drug, and Cosmetic Act and part 807 of this chapter. Investigational devices.(b) For an investigational medical device that has an investigational device exemption granted under section 520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational Device Exemption Number. For an investigational medical device being imported or offered for import for use in a nonsignificant risk or exempt study, “NSR” to be entered in the Affirmation of Compliance for the “investigational device exemption” that identifies the device as being used in a nonsignificant risk or exempt study. Premarket number.(c) For a medical device that has one, the Premarket Number. This is the Premarket Approval Number for those medical devices that…

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. Product name(a) which identifies the article being imported or offered for import by the name commonly associated with that article including the established name, trade name, brand name, proper name, or product description if the article does not have an established name, trade name, brand name, or proper name. HCT/P registration and affirmation.(b) (1) For an HCT/P regulated solely under section 361 of the Public Health Service Act and the regulations in part 1271 of this chapter that is manufactured by an establishment that is required to be registered under part 1271 of this chapter, the HCT/P Registration Number; and (2) For an HCT/P regulated solely under section 361 of the Public Health Service Act and the regulations in part 1271 of this chapter, an Affirmation of Compliance with the applicable requirements of part 1271 of this chapter. Licensed biological products.(c) For a biological…

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. Brand name(a) 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 submit a commercial name for the brand name. This data element is not applicable to those products solely intended either for further manufacturing or as investigational tobacco products. (b) [Reserved]

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: ownerconsignee(a) The term or 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.” division director(b) The term means the director of the division of the Food and Drug Administration having jurisdiction over the port of entry through which an article is imported or offered for import, or such officer of the division as he or she may designate to act on his or her behalf in administering and enforcing the provisions of section 801(a), (b), and (c). [42 FR 15553, Mar. 22, 1977, as amended at 81 FR 85872, Nov. 29, 2016; 85 FR 50781, Aug. 18, 2020]

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 notice from the division director or U.S. Customs and Border Protection of the results of examination of the sample. [85 FR 50781, Aug. 18, 2020]

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 import. Payment for samples will not be made if the article is found to be in violation of the act, even though subsequently brought into compliance under the terms of an authorization to bring the article into compliance or rendered not a food, drug, device, or cosmetic as set forth in § 1.95. [42 FR 15553, Mar. 22, 1977, as amended at 85 FR 50781, Aug. 18, 2020]

(a) If it appears that the article may be subject to refusal of admission or that the article is a drug 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, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility or destruction of the article, and may be introduced orally or in writing. (b) If such owner or consignee submits or indicates his or her intention to submit an 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, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing on refusal of admission, the division director…

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 into compliance with the act or rendering it other than a food, drug, device, or cosmetic. (b) Specify the time and place where such operations will be carried out and the approximate time for their completion. [42 FR 15553, Mar. 22, 1977, as amended at 85 FR 50781, Aug. 18, 2020]

(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 the supervision of an officer of the Food and Drug Administration or U.S. Customs and Border Protection, as appropriate; (4) A time limit, reasonable in the light of the circumstances, for completion of the operations; and (5) Such other conditions as are necessary to maintain adequate supervision and control over the article. (b) Upon receipt of a written request for extension of time to complete such operations, containing reasonable grounds therefor, the division director may grant such additional time as he or she deems necessary. (c) An authorization may be amended upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the division director. (d) If ownership of an article covered by an authorization changes before the operations specified in the authorization have been completed, the original owner…

(a) The bond requirements under section 801(b) of the Federal Food, Drug, and Cosmetic Act may be satisfied by the owner or consignee executing, on the appropriate U.S. Customs and Border Protection form, a single-transaction or continuous bond, containing a condition for the redelivery of the merchandise or any part thereof upon demand of U.S. Customs and Border Protection and containing a provision for the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic, in such manner as is prescribed for such bond in the customs regulations in force on the date of request for authorization. The bond shall be filed with U.S. Customs and Border Protection. (b) U.S. Customs and Border Protection may cancel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if U.S. Customs and Border Protection receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances,…

General.(a) This section sets forth the procedures for detention of drugs believed to be adulterated or misbranded. Administrative detention is intended to protect the public by preventing distribution or use of drugs encountered during inspections that may be adulterated or misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate. Drugs that FDA orders detained may not be used, moved, altered, or tampered with in any manner by any person during the detention period, except as authorized under paragraph (h) of this section, until FDA terminates the detention order under paragraph (j) of this section, or the detention period expires, whichever occurs first. Criteria for ordering detention.(b) Administrative detention of drugs may be ordered in accordance with this section when an authorized FDA representative, during an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act, has reason to believe that a drug, as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act, is adulterated or misbranded. Detention period.(c) The detention…

The cost of supervising the relabeling or other action in connection with an import of food, drugs, devices, or cosmetics which fails to comply with the Federal Food, Drug, and Cosmetic Act shall be paid by the owner or consignee who files an application requesting such action and executes a bond, pursuant to section 801(b) of the act, as amended. The cost of such supervision shall include, but not be restricted to, the following: (a) Travel expenses of the supervising officer. (b) Per diem in lieu of subsistence of the supervising officer when away from his or her home station, as provided by law. (c) The charge for the services of the supervising officer, which shall include administrative support, shall be computed at a rate per hour equal to 267 percent of the hourly rate of regular pay of a grade GS-11/4 employee, except that such services performed by a customs officer and subject to the provisions of the act of February 13, 1911, as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be calculated as provided in that act. (d) The charge for the service of the analyst, which shall include administrative and laboratory support, shall be computed at a rate…