PHP 316 Lecture Notes - Lecture 10: Prescription Drug Marketing Act, Medical Prescription, Pharmacy
Document Summary
Misbranded = tamper evident bottle, ppi not handed out by pharmacist. Fdca regulatory approach emphasis elimination/limitation of risks throughout distribution chain. Comprehensive activity that incorporated drug therapy monitoring and patient education as well as drug distribution: the durham-humphrey amendment of 1951. Co-sponsored by 2 pharmacy legislators: senator hubert humphrey, congressman carl durham. Created distinction between prescription and nonprescription (otc), verbal transmission of prescriptions and right for pharmacists to honor refill authorizations indicated by the doctor in the initial prescription. The law (pg 124-125) too much to write down. Before amendment, drug manufacturers determined whether their products were prescription or otc and no refills were allowed. If fda disagreed, had to sue for misbranding. Established criteria for classification of prescription drugs. Prescription vs otc: subsection (b)(1) gives fda authority to categorize prescriptions if they are. Unsafe for use except under supervision because of toxicity, method of use, or collateral measures necessary to use drug.
