Iâ€™ve been looking through a lot of the California State Board of Pharmacy requirements for sterile compounding logs and accompanying master formula records. The information can be found in the California Lawbook for Pharmacy 2013 [PDF], specifically California Code of Regulation (CCR), Article 4.5 Compounding.
In my opinion, the two sections that are going to create the most havoc in pharmacies are CCR 1735.2 and CCR 1735.3:
CCR 1735.2 â€“ Compounding Limitations and Requirements; Self-Assessment
(d) A drug product shall not be compounded until the pharmacy has first prepared a written master formula record that includes at least the following elements:
(1) Active ingredients to be used.
(2) Inactive ingredients to be used.
(3) Process and/or procedure used to prepare the drug.
(4) Quality reviews required at each step in preparation of the drug.
(5) Post-compounding process or procedures required, if any.
(6) Expiration dating requirements.
CCR 1735.3 â€“ Recordkeeping of Compounded Drug Product
(a) For each compounded drug product, the pharmacy records shall include:
(1) The master formula record.
(2) The date the drug product was compounded.
(3) The identity of the pharmacy personnel who compounded the drug product.
(4) The identity of the pharmacist reviewing the final drug product.
(5) The quantity of each component used in compounding the drug product.
(6) The manufacturer and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. Exempt from the requirements in this paragraph are sterile products compounded on a one-time basis for administration within twenty-four hours to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code.
(7) The equipment used in compounding the drug product.
(8) A pharmacy assigned reference or lot number for the compounded drug product.
(9) The expiration date of the final compounded drug product.
(10) The quantity or amount of drug product compounded.
Iâ€™ve been asking around to find out how hospitals are approaching the problem, i.e. how to manage the documentation, recordkeeping, etc. Most have simply decided to use good old pen and paper. That works, but itâ€™s time consuming and creates a giant headache should you ever need to go back and search through the documentation for a specific tid-bit of information.
I believe the best approach is to use some form of IV workflow management system along with software designed to help manage all the QA and other activities, formulas, documentation, etc in the clean room.
There are several IV workflow management systems to pick from – and each has pros and cons – Â so do your homework before purchasing one.
On the other hand, the software systems designed to manage the paperwork are a bit more limited. The two systems that Iâ€™m aware of are:
- ez797 from MedKeeper
- Simplifi 797 from Pharmacy OneSource