Description
'Distributor labeling’ refers to the labeling of an approved new animal drug marketed by a distributor who distributes the product under its own labeling rather than the approved labeling. Unlike the approved labeling, which CVM reviews as part of NADA/ANADA approval process to ensure the safe and effective use of the drug and compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, distributor labeling does not ordinarily go through a pre-market approval process.
Scope & Applicability
Product Classes
1Products subject to clinical investigation guidance.
Stakeholders
2Entity submitting development data and knowledge; Entity performing the work process for change
Entity responsible for submitting NDINs
Regulatory Context
Attributes
2Naming format required for other products in the combination regimen.
Commercial name granted by an authority for marketing
Related CFR Sections (6)
- 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 →
- 21CFR207.35§ 207.35 What changes require a new NDC?
(a) Once an NDC has been assigned by FDA, the registrant must propose a new and unique NDC for a drug when there is a change, after the drug is initially marketed, to any of the information identified in paragraphs (b) and (c) of this section. A new NDC must be proposed to FDA for assignment throughRead full regulation →
- 21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
- 21CFR201.2§ 201.2 Drugs and devices; National Drug Code numbers.
The National Drug Code (NDC) number is requested but not required to appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer.Read full regulation →
- 21CFR201.1§ 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
(a) A drug or drug product (as defined in § 320.1 of this chapter ) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply toRead full regulation →
- 21CFR514.3§ 514.3 Definitions.
The definition and interpretation of terms contained in this section apply to those terms as used throughout subchapter E.Read full regulation →
Related Warning Letters (1)
- 2020-03-03
False & Misleading Claims/Misbranded
Outlook Pharmaceuticals, Inc.
See Also (8)
- CVM GFI #240 Proprietary Names for New Animal Drugs (Status: Final)
- Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (Status: Draft)
- Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry (Status: Final)
- Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for Industry (Status: Final)
- Changes to an Approved NDA or ANDA: Guidance for Industry (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)