Description
This guidance is intended to assist requestors in preparing over-the-counter (OTC) monograph order requests (OMORs) for submission to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h). This guidance provides FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR and identifies relevant guidance documents to assist requestors in preparing their OMORs.
Scope & Applicability
Product Classes
1Nonprescription drugs marketed under section 505G of the FD&C Act; Drugs that meet applicable monograph conditions
Stakeholders
2Persons or organizations seeking designation of a method of manufacturing; Entity that has developed a technology and submitted an AMT designation request.
Representative of a foreign owner who serves as the FSVP importer; Person in the US acting as a communications link or FSVP representative.; Designated representative for foreign owners; designated representative for foreign owners
Regulatory Context
Attributes
5Section VI of the guidance addressing data privacy
Generally Recognized as Safe and Effective standards for drugs
Confidential information handled under 21 CFR Part 20.
Classification of an OMOR defined in section 744L
Classification of an OMOR for specific minor changes
Related CFR Sections (5)
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead 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 →
- 21CFR25.20§ 25.20 Actions requiring preparation of an environmental assessment.
Any proposed action of a type specified in this section normally requires at least the preparation of an EA, unless it is an action in a specific class that qualifies for exclusion under §§ 25.30 , 25.31 , 25.32 , 25.33 , 25.34 , or 25.35 :Read full regulation →
- 21CFR25.31§ 25.31 Human drugs and biologics.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
Related Warning Letters (9)
- 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.
- 2021-05-11
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.
- 2021-03-09
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
- 2020-11-10
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
JG Atlas Comercios, SA de CV
- 2020-01-21
Unapproved New Drugs/Misbranded
GOJO Industries Inc
See Also (8)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information (Status: Final)
- Applications for Premarket Review of New Tobacco Products: Draft Guidance for Industry (Status: Draft)
- Modified Risk Tobacco Product Applications: Draft Guidance for Industry (Status: Draft)
- Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products: Guidance for Industry (Status: Final)
- Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (Status: Final)
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (Status: Final)
- CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals (Status: Draft)