503A vs. 503B Compounding Pharmacies

503A Compounding: Medications are made per individual prescription. State regulated and FDA oversight is limited ensuring compliance with USP guidelines. 

• 503B Compounding: Can produce medications in bulk for office-use and distribute across state lines. Regular FDA inspections and strict regulatory oversight.

Processing is 5-7 business days (Monday through Friday, excluding weekends and holidays) and FedEx Pharmacy Delivery

• Opened (in-use) vials: May be stored at room temperature (up to 86°F or 30°C) for up to 28 days.

• Unopened vials: If refrigeration is not possible, some medications (like certain insulins) can be stored at room temperature for a limited time, such as up to 28 days or 42 days, provided the temperature remains below 86°F or 30°C and Kept away from direct sunlight. 

• However, it is generally recommended to store unopened vials in a refrigerator at 36°F or 46°C.

(https://www.fda.gov/drugs/emergency-preparedness-drugs/information-regarding-insulin-storage-and-switching-between-products-emergency)

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