Prescription Amendment

The Prescription Drug Marketing Act of 1988 amended the FD C Act to estabUsh newer safeguards for the national distribution of prescription dmg products. It limits the reimportation of dmg products manufactured in the United States to the product manufacturers only. It also prohibits the selling, trading, and purchasing of sample dmg products and places restrictions upon their distribution. 

Tliis law, passed in 1914, regulated the sale of narcotic drugp. Before the passage of this act, any narcotic could be purchased without a prescription. This law was amended many times. In 1970, the Harrison Narcotic Act was replaced with the passage of the Comprehensive Drug Abuse Prevention and Control Act. 

Passage of Durham-Humphrey Amendment. Provided the means for manufacturers to classify drugs as over-the-counter (not requiring prescription). 

Safe Medical Device Amendments, requiring more extensive testing of devices. 1992 Prescription Drug User Fee Act. Established the payment of fees for the filing of applications (e.g., IND, NDA, PLA, etc.)... 

The Durham-Humphrey Amendment defines drugs that cannot be used without a prescription from a... 

Under the Directive, the competent authorities are required to draw up a list of the medicinal products subject, on their territory, to medical prescription, specifying, if necessary, the category of classification. They should update this list annually. The Directive also requires that on the occasion of the 5-yearfy renewal of the marketing authorisation or when new facts are brought to their notice, the competent authorities should examine and, as appropriate, amend the classification of a medicinal product. Each year, Member States have to commrmicate to the EC and to the other Member States the changes that have been made to the list referred to above. 

The views of the Prescription Medicines Code of Practice Authority and the Code of Practice Appeal Board must be sought on any proposal to amend the Code or this Constitution and Procedure. The views of the Medicines and Healthcare products Regulatory Agency, the British Medical Association and the Royal Pharmaceutical... 

Durham-Humphrey Amendment (1951). Until this law, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should be used only under a doctor s supervision. 

This legislation amended the Federal Food, Drug, and Cosmetic Act to improve the regulation of prescription drugs (as well as medical devices and food). The law notes that the PDUFA of 1992 successfully reduced review times and reauthorized the user fees to expedite the review process. Other provisions aimed to give some patients access to experimental drugs. Beyond that, the law made several other changes. 

The Durham-Humphrey amendment, known as the prescription drug amendment, sets standards to distinguish prescription drugs that require supervision by a licensed health practitioner from less risky and harmful over-the-counter (OTC) drugs. 

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