Program Goal
This program provides a broad overview of the Food, Drug and Cosmetic Act, the Federal Controlled Substances Act and miscellaneous Federal laws to educate pharmacists on how to avoid legal problems in practice. Content in this program should help pharmacists prepare to study and pass the Multistate Pharmacy Jurisprudence Examination (MPJE) to obtain a pharmacy license.
Objectives
At the end of this program, participants should be able to:
- Explain the Federal Food Drug and Cosmetic Act's main historical events.
- Summarize the FDCA's main topics.
- Distinguish between adulterated and misbranded drugs.
- Demonstrate an understanding of the FDCA definition of "drug".
- Summarize FDCA's prohibited acts, penalties, and enforcement mechanisms.
- List the required information for a prescription label.
- Differentiate between compounding and manufacturing.
- Identify miscellaneous FDCA issues: out-of-state prescriptions; recalls; New Drug Applications / NDA.
- State the purpose of the Federal CSA.
- Distinguish the 5 schedules of controlled substances and match drugs from each schedule.
- Explain DEA registration requirements.
- Apply the concepts of "legitimate medical purpose" and "corresponding responsibility".
- Explain DEA labeling requirements.
- Describe DEA prescription & record-keeping rules for Schedule II (C-II) drugs & Schedule III-V (C-III, C-IV, C-V) drugs.
- Describe the limitations on drug samples and drug coupons.
- Explain the rules regarding child-resistant containers.
- Describe the Federal alcohol regulations regarding prescription drugs.
- Describe the Federal postal regulations regarding prescription drugs.
- Summarize the dispensing and recordkeeping requirements of the Federal Combat Methamphetamine Epidemic Act of 2005.
- Outline the prescriptive and dispensing requirements related to buprenorphine in narcotic treatment programs.
Target Audience
This program was developed for pharmacists and pharmacy technicians.
Faculty Disclosure
All faculty participating in the continuing pharmacy education activities sponsored by the University of Colorado School of Pharmacy are required to disclose to participants any real or apparent conflict of interest related to the content of their presentation(s). They are also required to disclose any investigational or unlabeled uses of products discussed. Dr. Smith reported that he has no commercial support affiliations or vested interests pertaining to this activity to disclose. He also reported that he does not discuss any unlabeled or investigational uses of products in this activity.
Faculty Bio
Michael Smith is an attorney and a pharmacist. He received his Juris Doctor from Wayne State University and his Doctor of Pharmacy from the University of Colorado School of Pharmacy. He teaches law and employment related courses for several universities, including the University of Phoenix and Troy University, as well as pharmacy law for the University of Colorado. He has practiced law, specializing in labor and employment law, for over 20 years. He also currently works part-time as a clinical pharmacist specializing in cardiac risk and anticoagulation in a health maintenance organization setting.
|
Macromedia Flash