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| Featured Article: Focus on Federal Pharmacy Law |
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As pharmacists we should be fully aware of the history and development of laws and regulations which govern the safe practice of manufacturing and dispensing medications in the United States. Did you know that the1938 Federal Food, Drug and Cosmetic Act (FDCA) actually was brought about by the deaths of 107 people who drank sulfanilamide Elixir which was mixed with diethylene glycol (car antifreeze)? In 1951 the Durham-Humphrey amendment went on to establish two main classes of drugs, namely, Rx and OTC'. Then in 1962, the Keafuver-Harris Amendments provided that drugs must be effective as well as safe. More recently in 1997, the FDA added one more caveat to be mix by stating that not only must all drugs be safe and effective, they must also be properly labeled.
Of course everyone knows that a lack of knowledge and/or of criminal intent provides no excuse in the eyes of the law. It is our responsibility as pharmacists to be fully knowledgeable regarding legal requirements and statutes governing the manufacture, distribution, labeling, prescribing and dispensing of medications. In fact, the FDA Controlled Substances Act clearly states that the responsibility for proper prescribing and dispensing of controlled substances is upon the prescriber, but a corresponding responsibility rests with the pharmacist who fills the prescription. " An order purported to be a prescription not in the usual course of professional treatment is not a prescription and the person knowingly filling it is subject to penalties under the Federal CSA."
This feature CE program "Pharmacy Law: What You Need to Know To Get and Keep Your License" provides a substantial overview of the Food, Drug and Cosmetic Act, The Federal Controlled Substances Act and a broad variety of miscellaneous Federal laws (including many case studies) that describe proper dispensing behavior and handling of drugs. Perhaps even more practical, this program is designed to educate pharmacists and pharmacy technicians about how to avoid legal problems in their professional practice environment. The content of this program will also help participants study for and pass the Multistate Pharmacy Jurisprudence Examination (MPJE) to obtain a pharmacy license.
To learn more about this and other important CE programs related to clinical practice and pharmacy law, please log onto RxSchool.com. This lesson is supported by The University of Colorado at Denver and Health Sciences Center.
Both RxSchool and The University of Colorado at Denver and Health Sciences Center are accredited by the Accreditation Council for Pharmacy Education as providers of pharmacy education. This three part home study web activity has been assigned a maximum of 3 credit hours (0.3 CEU's) and the ACPE UPN: 008-372-06-008-H03.
Please visit us at RxSchool.com to view the latest calendar of upcoming online Live CE Events as well as many other current CE lessons designed to enhance you professional development.
Contributed by:
Peter J. Rubino, M.S. Pharm., M.S., Ed.
Director, Continuing Professional Education
RxSchool.com
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