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Abstract
In the Fall of 2000 FDA recommended that phenylpropanolamine (PPA) be removed from OTC decongestant and weight control medications. The present paper reviews the regulatory history of PPA. Some of the broader implications of the PPA story which have general applicability are discussed. In particular, it is suggested that mature consideration of this case lends further credence to the validity of establishing in the United States an intermediate class of drug product for which a prescription is not required but for which sale can only be effected under the control of a licensed pharmacist.
Notes
*There are many more references on PPA than those given in this paper. References Citation70-74 provide information on additional papers.