Enhanced Content :: Cross Reference Show Displaying title 21, up to date as of 11/21/2022. Title 21 was last amended 11/21/2022. There have been changes in the last two weeks to Title 21.
eCFR Content
What is the name under which a drug is listed by the US FDA?The official name is the name under which a drug is listed by the FDA. The brand name, or trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic, name is provided by the U.S. Adopted Names Council.
Which of the following books contains official drug standards in the pharmacy?The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
What is a reference drug?A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA).
Which drug information resource defines the standards for medications?FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that: certain information is necessary to prevent serious adverse effects.
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Which drug reference is recognized by the u.s. government as its official list of drug standards?
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