Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products

Description

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.” This draft guidance provides recommendations to applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nonprescription drug products on documenting minor labeling changes in the next annual report and provides examples of minor labeling changes that may be submitted in an annual report. The recommendations in this draft guidance address the types of minor labeling changes that may be appropriate to submit in an annual report to ensure that consumers have timely access to the most current labeling for a nonprescription drug product to ensure the product’s safe and effective use. We anticipate that these recommendations may assist industry in understanding the circumstances in which it would be appropriate to document minor changes in the applicant’s next annual report rather than submitting a prior approval supplement or “changes being effected” supplement, thereby reducing burden on industry and FDA.

Scope & Applicability

Regulatory Context

• 21CFR211.132§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

  (a) General. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC drug products that will improve the security of OTC drug packaging and help assure the safety and eRead 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 →

• 21CFR314.71§ 314.71 Procedures for submission of a supplement to an approved application.

  (a) Only the applicant may submit a supplement to an application.Read full regulation →

• 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.

  (a) Changes to an approved NDA.Read full regulation →

• 21CFR201.5§ 201.5 Drugs; adequate directions for use.

  Adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended. ( Section 201.128 defines “intended use.”) Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specifRead full regulation →

• 21CFR314.97§ 314.97 Supplements and other changes to an approved ANDA.

  (a) General requirements. The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.Read full regulation →

• Unapproved New Drugs/Misbranded/Botox Blitz

  Aesthetic Essentials Limited

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• Unapproved New Drugs/Misbranded/Botox Blitz

  Elle Pharm

  2025-11-05

• Unapproved New Drugs/Misbranded/Botox

  COSMO KOREA

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• Unapproved New Drugs/Misbranded/Botox

  Glam Derma

  2025-11-05

• Unapproved New Drugs/Misbranded/Botox

  Meamo

  2025-11-05

• Unapproved New Drugs/Misbranded/Botox

  MJS Medicals

  2025-11-05

• Unapproved New Drugs/Misbranded/Botox

  Derma Solution

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• Unapproved New Drugs/Misbranded/Botox

  Glowface

  2025-11-05

• Unapproved New Drugs/Misbranded Botox

  Cosmenic

  2025-11-05

• Unapproved New Drugs/Misbranded Botox

  Dermacare dba Filler Outlet

  2025-11-05

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