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What are drug compendia?

What are drug compendia?

The compendia are resources providing comprehensive, organized data concerning FDA-approved medications and biologicals. The list includes pharmacology, dosages, recommended use in specific disease states, adverse reactions, and drug interactions.

What is a compendia approved condition?

Drug compendia are defined as summaries of drug information that are compiled by experts who have reviewed clinical data on drugs. Now, Medicare (both Parts B and D) relies on data from AHFS-DI, Clinical Pharmacology, DRUGDEX, and NCCN when making coverage decisions, while Medicaid utilizes only AHFS-DI and DRUGDEX.

What are compendia drugs examples?

3 These compendia are American Hospital Formulary Service-Drug Information (AHFS-DI), Micromedex DrugDEX (DrugDEX), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, and Clinical Pharmacology.

How often is official compendia published?

every year
compendia of the United States of America for excipients, drug substances, and drug products. It is published every year by the United States Pharmacopeial Convention (

What are the official compendia?

Official compendia are the compilation of drugs and other related substances which are recognized as legal standards of purity, quality and strength by government agency of respective countries of their origin.

What are the recognized Medicare compendia?

Based on the process for revising the list of compendia established in 2008, CMS currently recognizes the following four compendia: American Hospital Formulary Service-Drug Information (AHFS-DI), Truven Health Analytics Micromedex DrugDEX (DrugDEX), National Comprehensive Cancer Network (NCCN) Drugs and Biologics …

What is a Compendial method?

By compendial method, we mean methods that are described as chapters in the United States Pharmacopeia (USP) or others that may be applicable for a specific regulatory region.

Is BP same as EP?

The BP contains thousands of monographs and one of our areas of expertise is in finished products, while the EP predominantly focuses on starting materials and active pharmaceutical ingredients.

Which is not official compendia?

Non-official compendia: The books other than official drug compendia which are used as secondary reference sources for drugs and other related substances are known as non official drug compendia.

What are official compendia?

Does Medicare pay for off label usage?

Medicare Part D covers drugs prescribed for off-label use only if the drugs are identified as safe and effective for that use in one of three officially recognized drug compendia. “Compendia” are encyclopedias of drug chemicals, with information on dosage and usage.

What is the difference between method verification and validation?

Conclusion. In conclusion, method validation is usually applied to an “in-house method” developed by a laboratory; while method verification is applied to a “compendia method or previously validated method” when it is being use in a particular laboratory for the first time.

What are the requirements for a compendial test?

Compendial testing requirements are the same for products destined for commercial and military use unless the Defense Personnel Support Center (DPSC) insists upon certain requirements as part of military contracts.

When do you use a compendial release test?

Compendial methods need only be applied, as a batch release test, where a firm has made specific commitments to do so (as in a new drug application), or where the official method is the only appropriate test.

When to use the compendial method in drug testing?

However, in the event of a dispute as to whether or not a drug product meets the standard, the compendial method will be applied as the referee test. The term “specifications” as used in 21 CFR 211.165 refers to the criteria established by manufacturers to assure that their products have the properties they purport to possess.

Can a DPSC be used instead of a compendial test?

For example, DPSC can insist that only compendial methods be used and that each batch be tested for every monograph specification, whereas, as explained above, FDA considers that alternative procedures may sometimes be acceptable.