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Certificate of Analysis
CSP:Ephedrine Sulfate PF 5 mg/mL;
5mL in 5mL Syringe CSP Code:
Ingredients:7154601005Container/Volume:
Lot Code:
Compounded By:5mL Vol in 5mL Syringe
2019110569965D
Ephedrine
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What is hospital and ophthalmology 503b?
Hospital and ophthalmology 503b refers to a specific section of the U.S. Food and Drug Administration regulations that pertains to the compounding of sterile drugs by outsourcing facilities, particularly as they relate to hospitals and ophthalmology practices.
Who is required to file hospital and ophthalmology 503b?
Outsourcing facilities that compound sterile drugs and are involved in the provision of pharmaceutical products for hospitals and ophthalmology clinics are required to file under 503b.
How to fill out hospital and ophthalmology 503b?
Filling out hospital and ophthalmology 503b requires providing detailed information about the outsourced compounding facility, the drugs being compounded, and ensuring compliance with FDA regulations, including submitting the necessary forms electronically.
What is the purpose of hospital and ophthalmology 503b?
The purpose of hospital and ophthalmology 503b is to ensure the safe compounding of sterile drugs, prevent drug shortages, and maintain high standards in pharmaceutical practices within hospitals and ophthalmic settings.
What information must be reported on hospital and ophthalmology 503b?
Information that must be reported includes details about the outsourcing facility, product descriptions, quantity of drugs compounded, expiration dates, and any adverse events associated with the compounded drugs.
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