+17 Usp 797 Master Formulation Record Template. Preparation name, strength, and dosage form physical description of the. Based upon section 11.1 of usp 797;
Adheres to both usp 795 and usp 797 requirements and recognized by numerous boards of. Printable and fillable template for a master formulation record (napra) 1. Compounding environment should meet usp 797 medium risk sterile compound preparation requirement for batch compounding.
A master formulation record must be created for csps prepared for more than 1 patient and for csps prepared from nonsterile ingredient(s) Adheres to both usp 795 and usp 797 requirements and recognized by numerous boards of. Which info related to items used for compounding is required by usp 797 (2022) to be on the compounding record?
Usp 795 and 797 (for sterile preparations), as well as state boards of pharmacy (like nc and ky), regulate what components are required in a compounding record: Does anyone have a master formulation record/compounding log template you'd be willing to share that is in compliance with the new usp 795/797 regs on. The following is a best practice recommendation on the elements of a master formulation record.
The regional committee developed a compounding. Creating a compliant master formula record is crucial for hospital pharmacies to meet usp 795, usp 797, and board of pharmacy requirements. An mfr is a detailed record of procedures that describes how the csp is to be prepared.
Based upon section 11.1 of usp 797; Compounding environment should meet usp 797 medium risk sterile compound preparation requirement for batch compounding. Master formulation record is recommended when performing batch or high risk compounding.
Drug and pharmacies regulations act, s156 (3) exploring the requirements of master formulation. Simplify your pharmacy operations with the pharmacy master compounding worksheet. Usp 797 (2022) section 11.1 identifies all the information required on a master formulation record (mfr).
