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503A Regulatory Framework Key Regulations 503A pharmacies must: Meet state pharmacy board regulations and federal laws (section 503A of FD&C Act) Register with the Drug Enforcement Administration (DEA) if compounding and dispensing controlled substances Comply with USP , , and as applicable Conduct facility certifications every six months Assign Beyond Use Dates (BUDs) based on USP limits, supported by stability studies and/or general scientific literature reference Limit sterile batch sizes to 250 units (in states adopting USP ) They are statutorily exempt from FDA drug approval and cGMP requirements when operating in compliance with Section 503A conditions

SHIRLEY, NY 11967 NDC 0517-7350-01 Rx Only Sodium Phosphates Injection, USP 150 mM P/50 mL (3 mM P/mL) 200 mEq Na+/ 50 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 50 mL Single-Dose Vial Discard Unused Portion 25 Units/NDC 0517-7350-25 Rx Only Sodium Phosphates Injection, USP 150 mM P/50 mL (3 mM P/mL) 200 mEq Na+/ 50 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 50 mL Single-Dose Vial Discard Unused Portion AMERICAN REGENT, INC

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