Description
The Food and Drug Administration (FDA) is issuing this guidance to assist registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
Scope & Applicability
Product Classes
10Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Exempted when one lot treats a single patient
Exempted category of biological products
Drugs subject to reporting under section 510(j)(3)
Products marketed in accordance with requirements under section 505G
Active Pharmaceutical Ingredients for certain finished drugs
limit in active pharmaceutical ingredient (API) or drug product
Designated medical gases as defined in section 575 of the FD&C Act; Specific reporting requirements for cylinder, dewar, or tank units
Nonprescription drugs marketed under section 505G
RTRT and CTD sections apply to drug products
Stakeholders
7Person who registers a drug establishment under section 510; Person who registers with FDA and must report drug amounts; The entity responsible for listing drugs and submitting annual reports; Person that owns or operates an establishment that manufactures, repacks, relabels, or salvages a drug; Entity responsible for submitting drug amount reports
Responsible for data submission after ownership change
Person authorized by the registrant to submit reports on their behalf
External entity responsible for manufacturing activities
Entity that receives drug products for repacking.
Entity that receives drug products for relabeling.
Entity under whose trade name a drug may be distributed
Regulatory Context
Attributes
4information exempt from public disclosure
Predicted yield used as a comparison for actual yield
The actual amount of drug manufactured during the reporting period
A form suitable for distribution to pharmacies, hospitals, or dispensers
Identified Hazards
Hazards
2CARES Act authorities aim to assess, prevent, and mitigate shortages; Risk the Agency efforts to reduce through data visibility
Long term risk factors for drug shortages
Related CFR Sections (13)
- 21CFR207.57§ 207.57 What information must registrants submit when updating listing information and when?
Registrants must review and update listing information at a minimum, as follows:Read full regulation →
- 21CFR211.204§ 211.204 Returned drug products.
Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, or if the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts dRead full regulation →
- 21CFR514.87§ 514.87 Annual reports for antimicrobial animal drug sales and distribution.
(a) The applicant for each new animal drug product approved under section 512 of the Federal Food, Drug, and Cosmetic Act, or conditionally approved under section 571 of the Federal Food, Drug, and Cosmetic Act, and containing an antimicrobial active ingredient, must submit an annual report to FDA oRead full regulation →
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR600.81§ 600.81 Distribution reports.
(a) Reporting requirements. The applicant must submit to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. The intRead full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
- 21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
- 21CFR207.17§ 207.17 Who must register?
(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new aRead full regulation →
- 21CFR207.41§ 207.41 Who must list drugs and what drugs must they list?
(a) Each registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. Each domestic registrant must list each such drug regardless of whether the drug enters interstate commerce. When operations are conducted at more than one establishment, and comRead full regulation →
- 21CFR211.165§ 211.165 Testing and release for distribution.
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on sRead full regulation →
- 21CFR211.192§ 211.192 Production record review.
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (inRead full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
Turbare Manufacturing
- 2025-12-02
CGMP/Finished Pharmaceuticals/Adulterated
Rhyz Analytical Labs
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (Status: Final)
- Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide: Guidance for Industry (Status: Final)