The U.S. Pharmacopeia National Formulary 2018 (USP 41 - NF 36) is a hardcover book published by the United States Pharmacopeial Convention on May 1, 2018:
Publisher: United States Pharmacopeial Convention
Publication date: May 1, 2018
Dimensions: 25.4 x 41.91 x 40.64 cm
ISBN-10: 1936424703
ISBN-13: 978-1936424702
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The U.S. Pharmacopeia (USP) is a nonprofit organization that works to:
- Build trust in the supply of safe and quality medicines
- Strengthen the global supply chain
- Set public quality standards
The USP offers products and solutions, including:
- Reference Standards,
- USP–NF updates,
- USP Biologics,
- Impurities,
- Novel Excipients,
- Complex Generics, and
- Drug Shortages.
The USP also has a Public Policy Hub that includes: Policy issues by topic, Policy positions, and Latest statements and press releases.
The USP41-NF36 (United States Pharmacopeia 41 - National Formulary 36) is a comprehensive reference guide published by the United States Pharmacopeia (USP) in 2018. It is a critical resource for professionals in pharmaceuticals, healthcare, and laboratory sciences, as it provides detailed standards for the quality, purity, strength, and consistency of medicines, food ingredients, and dietary supplements.
Here's a breakdown of what USP41-NF36 covers and its significance:
Overview of USP41-NF36
- USP41-NF36 represents the 41st edition of the United States Pharmacopeia and the 36th edition of the National Formulary.
- The official text became effective on May 1, 2018.
- It sets legally enforceable standards under the Federal Food, Drug, and Cosmetic Act. It is used to ensure the identity, quality, and purity of drugs and excipients.
- Primarily intended for manufacturers, regulatory agencies, and practitioners involved in the healthcare and pharmaceutical sectors.
Structure and Content
- USP41-NF36 includes over 4,900 monographs for drug substances, dosage forms, and compounded preparations, as well as for dietary supplements and excipients. Each monograph details specifications for tests, methods, and acceptance criteria.
- These chapters provide methodologies and guidelines on topics like tests and assays, methods of analysis, microbial limit tests, sterility tests, and guidelines for laboratory practices.
- Key General Chapters include guidelines on chromatography, spectroscopy, dissolution, and other testing methods.
- Chapters are organized numerically, with those under <1000 considered enforceable by regulatory authorities.
- USP41-NF36 contains numerous revisions from the previous edition, updating test procedures, limits, and methods based on new research, scientific advancements, and regulatory changes.
- Each edition of USP-NF may include new monographs and general chapters addressing emerging needs in pharmacopoeial standards.
Importance of USP41-NF36
- Adhering to USP standards is required for any drug marketed or produced in the United States. USP standards are recognized and enforced by the FDA.
- The guidelines serve as the gold standard for quality control, helping manufacturers ensure their products meet the required specifications for safety and efficacy.
- Although specifically for the U.S., USP standards influence pharmacopoeial standards globally and are referenced by international regulatory authorities.
Application in Different Sectors
- Used by manufacturers to ensure raw materials, ingredients, and finished products meet quality specifications.
- Provides standards for the preparation and testing of compounded formulations.
- Agencies such as the FDA rely on USP standards for enforcing drug quality requirements.
- Laboratories use the USP for validated methods in drug development and stability testing.
Access and Availability
- USP41-NF36 is available as a printed book and also in digital format through the USP Online platform.
- Annual subscriptions to the USP-NF allow organizations to stay updated with new changes and revisions.
Other Notable Aspects
- USP41-NF36 emphasizes GMP guidelines, ensuring consistency and accuracy in manufacturing practices.
- Provides specific protocols for the testing and analysis of various dosage forms and excipients.
- USP provides mechanisms for stakeholders to comment on proposed changes or revisions and submit appeals if they disagree with compendial decisions.
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