What to know for the GA MPJE: Federal Law

The Georgia MPJE is largely focused on state-specific regulations, but this does not mean you can completely ignore federal statutes. One thing that makes preparation for this exam challenging is the amount redundancies and conflicts between the state and federal laws and rules. Here is my basic list of federal material to know for the exam that is not also covered by our state regulations:

- Review foundation laws and understand what they added, changed, or improved:

• Pure Food and Drug Act (1906) – Banned adulterated/misbranded drugs.
• Food, Drug, and Cosmetic Act (1938) – Required proof of drug safety before marketing.
• Durham-Humphrey Amendment (1951) – Created Rx vs. OTC categories.
• Kefauver-Harris Amendment (1962) – Required proof of efficacy for drugs.
• Poison Prevention Packaging Act (1970) – Required child-resistant containers.
• Medical Device Amendments (1976) – Regulated device safety and effectiveness.
• Hatch-Waxman Act (1984) – Allowed generics; gave brands exclusivity time.
• HIPAA (1996) – Protected patient health information.

- Review key concepts from Federal regulations:

• Misbranding vs. Adulteration

• Misbranding: Wrong or misleading label info
• Adulteration: Something wrong with the product itself

• FDA Recalls: Know the three classes and the pharmacist's role in each.
• 503A vs 503B Outsourcing Facilities: Know what makes a facility eligible for FDA registration.
• Orange and Purple Book Ratings: Know which ratings mean bioequivalent… (Only AB and BC matter for MPJE)
• Patient Package Inserts: Know when they must be given to patients.
• Child-resistant container requirements
• Compounding Standards: USP 795, 797, 800 (not everything, but understand basics)

- Review the DEA's Pharmacist Manual (https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist's_Manual_DEA.pdf) 

If you want a comprehensive review please check out www.GaPharmacyLawReview.com