Free Usp 797 Master Formulation Record Template. A master formulation record must be created for csps prepared for more than 1 patient and for csps prepared from nonsterile ingredient(s) Current usp797 2008 version only allows medium batch.
Figure 21. Bulk Compounding Formula Record (Master Formula Card from armymedical.tpub.com
A master formulation record (mfr), a detailed recipe for preparing a drug product, may be used as the basis for a cr by incorporating spaces to fill in the necessary information to complete. The following is a best practice recommendation on the elements of a master formulation record. Current usp797 2008 version only allows medium batch.
Drug And Pharmacies Regulations Act, S156 (3) Exploring The Requirements Of Master Formulation.
Usp 797 (2022) section 11.1 identifies all the information required on a master formulation record (mfr). The regional committee developed a compounding. A master formulation record is maintained for each batch of prepared csps and includes the following information:
Current Usp797 2008 Version Only Allows Medium Batch.
Creating a compliant master formula record is crucial for hospital pharmacies to meet usp 795, usp 797, and board of pharmacy requirements. 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. Which info related to items used for compounding is required by usp 797 (2022) to be on the compounding record?
Preparation Name, Strength, And Dosage Form Physical Description Of The.
An mfr is a detailed record of procedures that describes how the csp is to be prepared. 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: Simplify your pharmacy operations with the pharmacy master compounding worksheet.
Compounding Environment Should Meet Usp 797 Medium Risk Sterile Compound Preparation Requirement For Batch Compounding.
To provide a guideline to establish appropriate documentation. Based upon section 11.1 of usp 797; A master formulation record must be created for csps prepared for more than 1 patient and for csps prepared from nonsterile ingredient(s)
The Following Is A Best Practice Recommendation On The Elements Of A Master Formulation Record.
A master formulation record (mfr), a detailed recipe for preparing a drug product, may be used as the basis for a cr by incorporating spaces to fill in the necessary information to complete. A key provision of the regulations describes requirements for creating a master formula document, which is the specific recipe prepared in writing by a pharmacy before compounding any. Printable and fillable template for a master formulation record (napra) 1.
