Description
This guidance for industry is intended to help you, the sponsor, understand how products with 16 active ingredients that are salts may be affected by CDER’s implementation of the United States 17 Pharmacopeia (USP) policy entitled,Monograph Naming Policy for Salt Drug Substances in18Drug Products and Compounded Preparations2(the USP Salt Policy). Your involvement with 19 the implementation of this policy helps to ensure drug product naming that is consistent with the 20 USP Salt Policy, which became effective on May 1, 2013.
Scope & Applicability
Product Classes
2Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Products subject to program fees; Specific strength or potency of a drug in final dosage form
Stakeholders
2Distributor listed in the sample label.
Manufacturer listed in the sample label.
Regulatory Context
Attributes
3Storage condition requirement for the drug product.
controls in place to maintain the strength, composition, and purity
Naming format required for other products in the combination regimen.
Related CFR Sections (4)
- 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 →
- 21CFR314.108§ 314.108 New drug product exclusivity.
(a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead 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 (4)
- 2022-04-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Guangzhou Zhongkebaishi Health Industry 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.
- 2021-03-30
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Distribuidora Lagunera del Norte S.A. de C.V.
See Also (8)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Applications Covered by Section 505(b)(2) (Status: Draft)
- Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (Status: Draft)
- New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products (Status: Final)
- The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry (Status: Draft)
- Classification Categories for Certain Supplements Under BsUFA III (Status: Final)
- Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications (Status: Final)
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry (Status: Final)