Description
This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the- counter (OTC) drug monograph system and to describe the process for submitting that information.
Scope & Applicability
Product Classes
5drug products not subject to the requirements of section 503(b)(1)
Guidance provides a framework for over-the-counter drug products.
subject to 21 CFR part 111; Foods not subject to preventive controls requirements; Specific product category with modified FSVP requirements.; Included in human food sales calculation; foods not covered under systems recognition arrangements
Nonprescription drug products subject to the monograph system.
The regulatory framework for over-the-counter drugs.
Stakeholders
3Entity submitting development data and knowledge; Entity performing the work process for change
Any person or entity that can submit a TEA.
A body that may be used to evaluate safety and effectiveness data.
Regulatory Context
Attributes
6Statutory standard for marketing duration and volume
A category of actions that do not individually or cumulatively have a significant effect on the human environment.
Statutory standard for marketing duration and volume
Period of protected marketing for certain approved applications.
Information required in the TEA regarding the countries where the drug is marketed.
Defined as how often a drug product is to be used and for how long.
Related CFR Sections (6)
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
- 21CFR330.14§ 330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
This section sets forth additional criteria and procedures by which over-the-counter (OTC) drugs initially marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered in the OTC drug monograph system. This section also aRead full regulation →
- 21CFR310.545§ 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
(a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses:Read full regulation →
- 21CFR330.10§ 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
For purposes of classifying over-the-counter (OTC) drugs as drugs generally recognized among qualified experts as safe and effective for use and as not misbranded drugs, the following regulations shall apply:Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
Related Warning Letters (10)
- 2025-11-18
Nonprescription/OTC
Save Rite Medical
- 2025-11-18
Nonprescription/OTC
Medical Mega
- 2025-11-18
Nonprescription/OTC
Shoplet
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-08-12
Unapproved New Drugs/Misbranded
Confer With
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2024-07-30
Finished Pharmaceuticals/Unapproved New Drugs
ISIS.GOLD
- 2024-05-28
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Ward Smelling Salts
See Also (8)
- Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Redbook 2000: IV.C.9.b. Guidelines for Developmental Toxicity Studies (Status: Final)
- Redbook 2000: IV.C.9.a.Guidelines for Reproduction Studies (Status: Final)
- Redbook 2000: IV.C.5.b. One-Year Toxicity Studies with Non-Rodents (Status: Final)
- Redbook 2000: IV.C.4.b. Subchronic Toxicity Studies with Non-Rodents (Status: Final)
- Redbook 2000: IV.C.4.a. Subchronic Toxicity Studies with Rodents (Status: Final)
- Redbook 2000: IV.C.3.b. Short-Term Toxicity Studies with Non-Rodents (Status: Final)
- Redbook 2000: IV.C.3.a. Short-Term Toxicity Studies with Rodents (Status: Final)