Participants will successfully completepharmaceutical training, and all relatedactivities, to fulfill patient carerequirements commensurate with theduties of an upgraded militarypharmacy technician.
Understand and comply with major federal laws and pharmaceutical standards of practice regarding outpatient dispensing of pharmaceuticals. Identifylegal standards in documentation involved in medication dispensing e.g., patient prescriptions, Drug Enforcement Agency (DEA) numbers.
Constitutional Law Outlines the organization of the federal government All states must comply with constitutional law Overrides other laws—such as state law ◦ When there is a conflict between state and federal laws, the general standard of practice is to follow the most stringent law or practice
Food, Drug, and Cosmetic Act (FDCA) of 1938 The FDCA of 1938 stems from (amended) the 1906 Federal Pure Food and Drug Act Both Acts mainly dealt with prohibiting adulteration and misbranding of drugs…The laws also encompasses many aspects of consumer protection Adulteration occurs if a product contains any filthy, putrid, or decomposed substance. A drug is adulterated when it is packed or held under unsanitary conditions or when its strength, purity, or quality does not comply with its label Misbranding results if the label is false or misleading, or if it does not contain directions for use, precautions, and in some cases, the statement, “Warning—May Be Habit Forming.” It also applies to pharmacists who supply or refill prescription drugs without prescriber authorization
Kefauver-Harris Amendment (KHA) The FDCA required that a product’s safety must be proven; it did not, however, require proof of efficacy, or effectiveness before approval from The Food and Drug Administration, (FDA). Therefore, drugs were not subject to rigorous testing before approval. The Kefauver-Harris Amendment (KHA) of 1962 is best noted for requiring proof of efficacy of drugs before the FDA approved them. The KHA applies to all drugs introduced after 1962 and drugs that had new applications approved from 1938 to 1962.
This is the last slide for this part of the lesson. Pleaseclose this lesson and watch the two short You Tube clips,lesson video 1 on the Pure Food and Drug Act, and lessonvideo 2 on the Kefauver-Harris Amendment. Upon completion of the You Tube video 2 clip, Kefauver-Harris Amendment, use your knowledge of KHA to blog your thoughts on the Rx Law Review Chat, then continue with Pharmacy Law Lesson part 2.