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This document outlines the records and verification processes essential for compounding pharmacies, detailing the requirements for formulation records, compounding records, and Quality Control measures

How to fill out compounding records and verification

How to fill out Compounding Records and Verification Documents

1. Gather all necessary materials and documentation relevant to the compounding process.
2. Fill out the date and time of compounding at the top of the record.
3. Document the names and quantities of all ingredients used in the compounding process.
4. Record the specific batch or lot numbers for each ingredient.
5. Include the names of the personnel involved in the compounding process.
6. Note the method of compounding and any equipment used.
7. Indicate any special observations or steps taken during compounding.
8. Verify the entries for accuracy and completeness after compounding.
9. Sign and date the compounding record, as well as have the verifier sign it.

Who needs Compounding Records and Verification Documents?

1. Pharmacists involved in the compounding process.
2. Pharmacy technicians participating in compounding.
3. Regulatory auditors and inspectors reviewing adherence to compounding standards.
4. Healthcare providers requiring verification of compounded medications.
5. Quality assurance personnel responsible for monitoring compounding practices.

People Also Ask about

What quality control procedures are required to be documented on the compounding record?

Standard Operating Procedures. Formulation Record. Compounding Record. Ingredient Records. Safety Data Sheets (Formerly Material Safety Data Sheets) Certificates of Analysis. Hazardous Drugs Documentation. Record Maintenance.

Why is documentation necessary in compounding?

Documentation serves as a record of compounding activities and does not impact patient safety or quality assurance. Documentation is essential for maintaining accountability, ensuring patient safety, legal compliance, and quality assurance.

What is a compounding record?

Documentation serves as a record of compounding activities and does not impact patient safety or quality assurance. Documentation is essential for maintaining accountability, ensuring patient safety, legal compliance, and quality assurance.

What must be documented in the compounding record?

The information that needs to be documented in a compound record includes name, dose, and strength of the drug; master formulation record information; ingredients; total amount produced; name of all pharmacists involved in the compounding; date; prescription number; label information; and quality control information.

What information needs to be documented in the compounding record?

The information that needs to be documented in a compound record includes name, dose, and strength of the drug; master formulation record information; ingredients; total amount produced; name of all pharmacists involved in the compounding; date; prescription number; label information; and quality control information.

For pdfFiller’s FAQs

What is Compounding Records and Verification Documents?

Compounding Records and Verification Documents are official records maintained by a pharmacy or compounding facility that detail the processes and formulations used in the compounding of medications. They serve to ensure accuracy, quality control, and compliance with regulatory standards.

Who is required to file Compounding Records and Verification Documents?

Pharmacies, compounding facilities, and any entities involved in the preparation of compounded medications are required to file Compounding Records and Verification Documents to ensure proper documentation and adherence to regulatory requirements.

How to fill out Compounding Records and Verification Documents?

To fill out Compounding Records and Verification Documents, individuals should accurately enter data regarding the medication preparation process, including ingredients, amounts, preparation methods, quality control checks, and signatures of the personnel involved in the compounding process.

What is the purpose of Compounding Records and Verification Documents?

The purpose of Compounding Records and Verification Documents is to provide a detailed account of the compounding process to ensure safety, efficacy, and regulatory compliance. They also serve as a reference for audits and quality assurance measures.

What information must be reported on Compounding Records and Verification Documents?

The information that must be reported includes the date of compounding, a description of the compounded product, the list of ingredients used, quantities, lot numbers, expiration dates, the identity of the compounding personnel, and any quality control results.