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
- 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).
- 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.
- 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.
- 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
- Illinois Pharmacy Practice Act (225 ILCS 85) https://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID=24
- Illinois Pharmacy Practice Act Administrative Code (Part 1330): https://www.ilga.gov/commission/jcar/admincode/068/06801330sections.html
- Illinois Controlled Substances Act (720 ILCS 570) https://ilga.gov/legislation/ilcs/ilcs5.asp?ActID=1941&ChapterID=53
- Illinois Controlled Substances Act Administrative Code (Part 3100) https://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html
- 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