Prescription drugs, regulation

Swann, J.P. FDA and the practice of pharmacy Prescription drug regulation before the Durham-Humphrey amendment of 1951. Pharm. Hist. 1994, 36, 55 70. 

M. Danish and S. Rosenbaum, Dosing considerations for non-prescription drugs in infants and children, Clin. Res. Regul. Affairs, 9, 89 (1992). 

However, the situation most commonly recognized is that competition in the market of patented prescription drugs is insufficient to produce an optimum level of information or an optimum level of welfare, which makes it necessary to establish some form of regulation. However, price regulation in the markets of non-prescription drugs and drugs whose patent has expired lacks theoretical justification. 

The term black market, in this case, applies to a source of prescription drugs other than a retail store or a corner pharmacy (which are regulated by the government). Anyone can easily perform a search on the Internet for diet... 

Temen, P. (1980) Regulation and Choice of Prescription Drugs, American Economic Review, 70 301-305. 

Specific requirements on content and format of labeling for human prescription drugs warnings Title 21 Code of Federal Regulations, Part 201.57(e), pp. 23, revised 2003. 

Prescription drugs must have Food and Drug Administration (FDA) approval as safe and effective for their intended purposes and are tightly regulated. To gain approval, they must undergo laboratory tests and well-designed clinical trials that demonstrate safety... 

Establishes national uniformity in the regulation of non-prescription drugs. 

The adulteration and misbranding provisions of the statute itself are continually expanded by FDA regulations that impose additional requirements either for all non-prescription drugs or for... 

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