Usp 797 beyond use dating

22-Oct-2017 09:21

USP 797 is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. You can also download the entire ASHP Discussion Guide for Compounding Sterile Preparations document here.The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products. Source of base information: Pharmacopeial Form - Volume 29 (4) July - August 2003Effective Date: January 1, 2004 FDA enforceable: yes Scope - "The content of this chapter applies to health care institutions, pharmacies, physicians practice facilities and other facilities in which compounds sterile preparations are prepared, stored and dispensed." Facilities Impacted by USP 797 Medium Risk Conditions: Multiple individual or small doses of sterile products are compounded or pooled to prepare a compound sterile product that will be administered either to multiple patients or to one patient on multiple occasions.In conversations with other physicians under these guidelines they have increased the frequency of injections to advance the dose.Thank you again for your inquiry and we hope this response is helpful to you.The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements.

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More information can be found at the General Notices page.

Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP.