U.S. Federal Drug

TABLE 2.1. Important Dates in U.S. Federal Drug Law3... 

U.S. Army Medical Command. (1999). Medical management of chemical casualties course, medical response to chemical warfare and terrorism [Satellite broadcast]. Aberdeen Proving Ground, MD U.S. Army Medical Research Institute for Chemical Defense and U.S. Federal Drug Administration. 

In 2002, the company started work on projects to improve product traceability. The U.S. Federal Drug Administration (FDA) report of 2002 was the catalyst. Flowever, at the start, the team could not do much. 

U.S. Food Drug Administration, Code of Federal Regulations. Title 21—... 

U S Code of Federal Regulations 21 CFR Part 314 21 CFR Part 514 21 CFR Part 601 U S Food, Drug Cosmetic Act Chapter 5, Sub chapter B, F... 

Source Adapted from Francis, F.J., in Colorants, Eagan Press, St. Paul, MN, 1999 Commission Directive 95/45/EC, Ojf. J. European Commun., L226, 22.09, 1995 U.S. Food Drug Administration, Code of Federal Regulations, 21 CFR 73, 615 U.S. Food Drug Administration, Additives Listed for Use, etc., 1999 Downham, A. and Collins, P, J. Food Sci. Technol, 35, 5, 2000 JECFA, Geneva, 2001. 

The USP was combined as a compendium with the National Formulary (NF) in 1975. Currently, the USP gives information regarding substances considered as having active medicinal properties while pharmaceutically inactive necessities are described in NF. The combined United States Pharmacopeia and National Formulary (USP-NF) is legally recognized under the U.S. Federal Food, Drug and Cosmetic Act. 

Some legal limits make no scientific sense. The Delaney Amendment to the U.S. Federal Food, Drug, and Cosmetic Act of... 

Should citizens of the United States have the right to buy prescription drugs from Canada at competitive prices Why does the U.S. federal government discourage such a practice ... 

The Wheeler-Lea Act empowers U.S. Federal Trade Commission with the oversight of non-prescription drug advertising otherwise regulated by FDA. 

Ephedra is subject to the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994. The act essentially protects dietary supplements like ephedra. That is, while U.S. federal agencies can regulate prescription drug and food additives, DSHEA exempts herbal products and supplements from federal regulation. The law states that the United States Food and Drug Administration (FDA) cannot regulate dietary supplements unless, or until, they are proven to be unsafe and pose a risk to users. The United States Drug Enforcement Administration (DEA) monitors ephedrine because it can be used to make methamphetamine. 

PCP was first listed by the U.S. federal government as a Schedule III substance in the 1960s. That meant it was legal for use in certain medical settings. However, it was changed to a Schedule II drug in 1978 because of reports of considerable abuse of the drug on the street. 

Although using marijuana for medical purposes is illegal because U.S. federal law classifies marijuana as a Schedule I drug, states are not obligated to mirror federal laws. Many states have therefore created their own provisions for the medicinal use of marijuana. For example, in the 1970s,... 

The USP and NF standards of strength, quality, purity, and packaging and labeling are recognized by the U.S. Federal Food, Drug, and Cosmetic Act and Amendments since 1906. These requirements are enforced by the Food and Drug Administration (FDA), a party in the harmonization of requirements for drugs. 

One serious discrepancy exists between requirements in this Pharmacopeia and ICH guidelines beyond the relative mandatory status. USP-NF requirements are enforceable by U.S. federal and state laws and regulations. The standards give the attributes of acceptable articles already used in healthcare. A key contrast can be seen in the strict focus of the ICH, which is explicit in treating new drugs, that is, those not yet in use. The situations differ dramatically in practical consequences and breadth of application. Therefore, the goal of harmonization in some cases is not currently achievable because justification does not exist to disturb many established products in favor of the most recent new drug approval practices. 

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