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

コンテンツは Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャストコンテンツは、Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel またはそのポッドキャストプラットフォームパートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal。

8M ago 56:45

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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

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