Whois & Analysis for uspnf.com

The United States Pharmacopoeia (USP) is a pharmacopoeia (compendium of drug information) for the United States published annually by the United States Pharmacopoeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and copyright.

The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF.

If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF." Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise), as well as animal drugs.

USP-NF standards also have a role in U.S. federal law; a drug or drug ingredient with a name recognized in USP-NF is deemed adulterated if it does not satisfy compendial standards for strength, quality or purity.

USP also sets standards for dietary supplements, and food ingredients (as part of the Food Chemicals Codex).

USP has no role in enforcing its standards; enforcement is the responsibility of FDA and other government authorities in the U.S. and elsewhere.

At its most basic level, a formulary is a list of medicines.

Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication (a resource closer to what would be referred to as a pharmacopoeia today).

Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy.

The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.

A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.

Terms like "combination drug" or "combination drug product" can be common shorthand for a FDC product (since most combination drug products are currently FDCs), although the latter is more precise if in fact referring to a mass-produced product having a predetermined combination of drugs and respective dosages (as opposed to customized polypharmacy via compounding).

And it should also be distinguished from the term "combination product" in medical contexts, which without further specification can refer to products that combine different types of medical products - such as device/drug combinations as opposed to drug/drug combinations.

Note that when a combination drug product (whether fixed-dose or not) is a "pill" (i.e., a tablet or capsule), then it is also a kind of "polypill" or combopill.