178 - Law & Order: Pharmacy Edition. A Concise Review of High-Yield Pharmacy Law Topics for the MPJE

HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

In this episode, we speak with Janeen Winnike, the Associate Dean for Student Affairs at Rosalind Franklin and a co-course director for the Pharmacy Law course at the university. We review some of the key points regarding federal and Illinois pharmacy law – a must-listen especially for graduates preparing for their MPJE exam after graduation!

Key Concepts

1. The FDA (via the Food, Drug, and Cosmetic Act) primarily regulates manufacturers. Most regulation for pharmacies and pharmacists is via the federal Controlled Substances Act and state-based regulations (acts and administrative codes).
2. An IND (investigational drug application) is required to begin human clinical trials (phase I-III). An NDA (new drug application) is used for the FDA to consider whether a drug should be approved for use in the US.
3. The Federal Controlled Substances Act outlines which drugs are scheduled I-V. State law can be more restrictive. C-II drugs have special regulations related to prescribing, ordering/distribution, refills, partial fills, etc.
4. In Illinois, pharmacists, student pharmacists, and pharmacy technicians are permitted to vaccinate patients aged 7 years and older (or temporarily 3 years and older per the PREP act for COVID-19 and influenza vaccines). Pharmacists can order and administer COVID-19 and influenza vaccines; other vaccines require a standing order or a prescription in order prior to administration in a pharmacy.

References

1. Illinois Pharmacy Practice Act (225 ILCS 85) https://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID=24
2. Illinois Pharmacy Practice Act Administrative Code (Part 1330): https://www.ilga.gov/commission/jcar/admincode/068/06801330sections.html
3. Illinois Controlled Substances Act (720 ILCS 570) https://ilga.gov/legislation/ilcs/ilcs5.asp?ActID=1941&ChapterID=53
4. Illinois Controlled Substances Act Administrative Code (Part 3100) https://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html
5. Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. Drug Enforcement Administration. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist%27s_Manual_DEA.pdf