Texas Administrative Code Changes To Significantly Impact Sterile Compounding Pharmacies

The fungal meningitis outbreak traced back to the New England Compounding Center (NECC) in Massachusetts In October 2012 caused ripples in the pharmacy community that will forever change the way hospitals practice sterile compounding. Many states were directly impacted by the tragedy, including Texas. While the number of patients affected in Texas was not as great as in many other states, the Texas State Board of Pharmacy has taken steps to increase regulatory oversight of hospital pharmacies.¹
As recently as December 2013, the Texas State Board of Pharmacy made changes to rules and laws that will have a significant impact on sterile compounding in institutional (hospital) pharmacy practices.² The recent changes include the addition of a new license, the Class C-S license, for institutional pharmacies that wish to continue compounding sterile preparations. According to Title 22, Part 15, Chapter 291, Subchapter D, Rule §291.74 of the Texas Administrative Code, “Effective August 31, 2014, a Class C pharmacy shall not compound sterile preparations unless the pharmacy has applied for and obtained a Class C-S pharmacy [license]“.
Class C-S pharmacy licensing requirements can be found in Rule §291.77 of the same Subchapter and includes a provision that all institutional pharmacies must be inspected by the board and meet the requirements of Rule §291.133 prior to being licensed.
Rule §291.133³ covers the requirements for record keeping, compound verification, labeling, training, and quality assurance for all compounded sterile preparations (CSPs). Under the rule CSP production will require significant and continuous pharmacist oversight throughout the entire compounding process. According to §291.133 “At each step of the compounding process, the pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate to conform to the formula being prepared”.
Furthermore, each CSP prepared will require detailed documentation that must be maintained by the pharmacy electronically or manually. Documentation required includes:

1. The date of preparation
2. A complete formula, including methodology and necessary equipment
3. Signature or initials of the person performing the compounding
4. Signature or initials of the pharmacist supervising the compounder and conducting in-process and finals checks of compounded products
5. The quantity in units of finished preparation or amount of raw materials
6. The container used and the number of units prepared; and
7. A reference to the criteria used to determine the beyond-use date.

CSPs prepared in batches will require additional documentation to include:

1. A master work sheet containing at a minimum:
   1. The formula
   2. The components used
   3. The compounding directions
   4. A sample label
   5. Evaluation and testing requirements
   6. Specific equipment used during preparation
   7. Storage requirements
2. A preparation work sheet for each batch of CSPs documenting the following:
   1. Identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes
   2. Lot number for each component
   3. Component manufacturer/distributor or suitable identifying number
   4. Container specifications (e.g., syringe, pump cassette)
   5. Unique lot or control number assigned to batch
   6. Expiration date of batch-prepared preparations
   7. Date of preparation
   8. Name, initials, or electronic signature of the person(s) involved in the preparation
   9. Name, initials, or electronic signature of the responsible pharmacist
   10. Finished preparation evaluation and testing specifications, if applicable
   11. Comparison of actual yield to anticipated or theoretical yield, when appropriate.

The good news is there are products on the market that provide full compliance with all sterile preparation requirements. Be sure to look for a queue-based IV room workflow management system that is designed and delivered to help pharmacies ensure IV compounds are processed timely, correctly, and in a consistent manner through the use of customer-designed workflows, bar code verification scanning and image capture.
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