Drug and Pharmacology Resources: Regulatory Information

DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.

"The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries."

"The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States."

All the key databases and resources you need from the FDA. Including: Acronyms and Abbreviations Search; Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Search;Drug Shortages; Drugs@FDA Search; FDA Adverse Event Reporting System (FAERS) Quarterly Data Files; Inactive Ingredient Search for Approved Drug Products Search; National Drug Code Directory Search

"The Purple Book is available as lists and a database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products...including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act. Currently, the lists contain information about all FDA licensed biological products. The new, searchable database contains information about a limited number of FDA-licensed biological products: licensed biosimilar and interchangeable products, and their reference products.

"The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily."