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Pharmacy Owners: Beware of These 503B Red Flags! | Becoming A Pharmacy Badass

Author
Pharmacy Podcast Network
Published
Sat 22 Mar 2025
Episode Link
https://diversifyrx.podbean.com/e/pharmacy-owners-beware-of-these-503b-red-flags-becoming-a-pharmacy-badass/

**Today, I’m breaking down everything you NEED to know about 503B pharmacies and FDA 483 reports—and trust me, this is critical info for protecting your business and your patients.**




**Show Notes:**

1. **Understanding 503B and 503A Pharmacies** [0:00]

2. **FDA Inspections and 483 Letters** [4:16]

3. **Vetting 503B Pharmacies** [11:17]

4. **Risks and Recommendations** [13:14]

5. **Conclusion and Resources** [13:28]

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**Links mentioned in this episode:**

ProRx 

FDA Letter - it's atrocious... 

(https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-696742-12202024)  


Medivant 

FDA Letter 2022 - awful and very similar to ProRx (https://www.fda.gov/media/163521/download?fbclid=IwY2xjawIIochleHRuA2FlbQIxMAABHdvrPVsxdboN8lfH4PBOdnLrAgeVDUkPnlIGO1-FMlxLsglqYbPuUIn77w_aem_lf6-woZuSn-XuHsSAwU18w) 


FDA Letter 2024 483 - they obviously haven't learned to improve (https://www.fda.gov/media/184179/download) 


Websites Mentioned:

https://diversifyrx.com/503b-playbook-for-pharmacy-owners/

https://diversifyrx.com/weekly-awesomeness-newsletter/

https://www.drlisafaast.com/


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