Saturday Mar 22, 2025
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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