Description
This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products marketed under abbreviated new drug applications (ANDAs) and the manufacturers of corresponding reference listed drugs (RLDs) implement the Agency's regulation on standardized content and format requirements for the labeling of OTC drug products. The guidance contains recommendations on how RLD and ANDA holders can update their labeling in a timely manner consistent with the regulation on OTC drug product labeling (21 CFR 201.66).
Scope & Applicability
Product Classes
3Reference Listed Drug used as the basis for an ANDA submission.
Generic drug products marketed under an ANDA
Guidance provides a framework for over-the-counter drug products.
Stakeholders
5Holder of the reference listed drug application
Entity responsible for maintaining generic drug labeling
Entity involved in investigational drug supply chain
Entity required to maintain records of lot numbers for food released; Entity required to establish and maintain records under subpart J.
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Regulatory Context
Attributes
1requirement that ANDA must bear the same labeling as the RLD
Related CFR Sections (5)
- 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 →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR330.1§ 330.1 General conditions for general recognition as safe, effective and not misbranded.
An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the cRead full regulation →
- 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →
Related Warning Letters (10)
- 2022-04-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Zhongkebaishi Health Industry Co., Ltd.
- 2021-12-21
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangdong Kemei Pharmaceutical Technology Co. Ltd.
- 2021-10-12
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Notarika, S.A. de C.V.
- 2021-07-13
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Minghui Cosmetics Co., Ltd.
- 2021-05-11
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Ismar Soluciones Dinámicas S de RL de CV
- 2021-05-11
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
C&G Laboratorios SA de CV
- 2021-04-13
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
MYM Hidrominerales S.A. de C.V.
- 2021-03-30
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Distribuidora Lagunera del Norte S.A. de C.V.
- 2021-03-09
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Plasticos Las Palmas, S.A. de C.V
- 2021-01-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Ignacio Reyes Gonzalez
See Also (8)
- PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 (Status: Final)
- Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (Status: Final)
- Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry (Status: Draft)
- Orange Book Questions and Answers Guidance for Industry: Guidance for Industry (Status: Final)
- Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry (Status: Final)
- Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (Status: Final)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- Format and Content of a REMS Document Guidance for Industry (Status: Final)