Section 12.4: Compounding Recordkeeping & Quality Control

Section 12.4: Compounding Recordkeeping & Quality Control

Maintaining rigorous documentation and quality control systems is a legal mandate for all compounding pharmacies in Texas. Accurate records are required during audits and provide traceability in the event of patient harm or a product recall. The Texas State Board of Pharmacy (TSBP) enforces strict recordkeeping guidelines under 22 TAC §291.131 and §291.133.

Master Formulation Record vs. Compounding Record

TSBP rules require two distinct, legally mandated documents for compounding activities:

1. Master Formulation Record (MFR)

The MFR is the pharmacy's "master recipe." It is a pre-established, written document that provides the standard instructions for preparing a compounded preparation.

• When Required: An MFR must be created for any compounded preparation prepared in a batch (more than one patient dose at a time) or when preparing a compound from raw bulk chemicals. It is not required for a simple, non-repetitive compound prepared for a single patient using a commercial product.
• Required Contents: The MFR must contain: the name, strength, and dosage form; calculations; all ingredients and their quantities; necessary equipment; step-by-step mixing instructions; quality control procedures (e.g., pH testing, visual check parameters); labeling information, including storage instructions; the container-closure system; and the scientific source or stability literature used to justify the assigned beyond-use date (BUD).

2. Compounding Record (CR)

The CR is the actual "log" of the compounding event, completed during the preparation of a specific batch or individual prescription.

• When Required: A CR must be completed every single time a compounded preparation (sterile or non-sterile) is prepared. If a commercial drug product is manipulated, the lot number and expiration date of that commercial product must be logged.
• Required Contents: The CR must contain: the name, strength, and dosage form; reference to the matching MFR; the date and time of compounding; a unique prescription number or batch control number; actual weights and measures of ingredients; manufacturer, lot number, and expiration date of each ingredient; total quantity prepared; signatures of the compounding technician and the verifying pharmacist; assigned BUD; results of quality control procedures; and documentation of any compounding issues or deviations.

Record Retention and the TSBP "72-Hour Rule"

All records relating to non-sterile and sterile compounding—including MFRs, CRs, purchase invoices, Certificates of Analysis (COAs), cleaning logs, temperature logs, and training records—must be maintained by the pharmacy for at least two years from the date of the record. These records must be kept secure but accessible.

The 72-Hour Rule

Under TSBP regulations, a pharmacy must make compounding records available to an authorized agent of the Board upon request. If the records are stored off-site, in an electronic archive, or on microfilm, the pharmacy must produce and deliver these records within 72 hours of the request. Under Texas law, a failure to provide requested records within 72 hours is considered prima facie evidence of a failure to maintain records, which constitutes a major licensing violation and may result in disciplinary action against both the pharmacy license and the PIC's license.

Recall Procedures and TSBP Notification Timelines

If a pharmacy compounds a preparation that is found to be defective, contaminated, or has caused patient harm, the pharmacy must immediately initiate a recall, removing it from inventory and contacting recipients. However, specific TSBP reporting timelines differ based on the compound type:

• Immediate Recall: Cease compounding and recall the affected preparation. The PIC must ensure that all practitioners, facilities, and patients who received the compound are notified in writing immediately.
• 24-Hour Board Notification: In the event of a recall of a compounded sterile preparation, the PIC must submit a written notification of the recall to the TSBP no later than 24 hours after the recall is issued. For non-sterile compounding recalls, while the pharmacy must immediately contact patients and practitioners, there is no mandatory 24-hour written reporting requirement to the TSBP unless patient harm has occurred.
• DSHS Notification: If the recalled sterile compound was distributed for office use or prepared as a large batch, the PIC must also notify the Texas Department of State Health Services (DSHS) Drugs and Medical Devices Group in writing within the same 24-hour window.

Office-Use and Practitioner Compounding in Texas

Texas pharmacy law allows a Class A or Class C pharmacy to compound preparations for a physician or other licensed practitioner to use in their office under these strict conditions:

• Written Agreement: The pharmacy and the practitioner must enter into a formal, written agreement before any office-use compounding occurs. The agreement must state that the compounded preparation is for office administration only and shall not be dispensed or resold to patients. It must also detail how adverse events are reported to the pharmacy.
• Labeling: The container of any compound distributed for office use must carry a label that includes the statement: "For Institutional or Office Use Only - Not for Resale" (or, if veterinary, "Compounded Preparation for Veterinary Office Use Only - Not for Resale").
• Limitations: Traditional 503A pharmacies must ensure that compounding for office use does not exceed a reasonable quantity. To legally perform bulk, non-patient-specific sterile compounding for widespread distribution, the facility must register as a Section 503B Outsourcing Facility and obtain a Class DSM license from the TSBP.