New Pharmacy compounding regulations for California have undergone multiple iterations since last year, with the latest version set to be approved. In February the board of pharmacy voted for these regulations to take effect immediately upon being approved by the CA Office of Administrative Law (OAL) despite commentary from numerous stakeholders requesting a buffer period to account for operational lag time. Most of the push back came from the inclusion in the new regulations of certain parts of the newly published USP <800> for hazardous drugs in health care settings.
The new California regulations for pharmacy compounding are expected to become law as early as January 1, 2017. This gives California compounders and CA-licensed non-resident pharmacies a little over six months to become compliant with the new laws. In addition to new definitions, CA has also added details for facilities and equipment needed for the safe handling and manipulation of hazardous drugs similar to USP <800>. The following is a summary of major highlights compounders should be aware of immediately in order to prepare for the January 1, 2017 live date. In this paper the language in the California regulations is examined to understand what these new requirements are, learn how facilities can be set up to comply with them, answer some frequently asked questions, and differentiate between the CA regulations and USP <800>. For complete information on all new compounding regulations, click here.
READ: Final Compounding Regulations for California: Hazardous Drug Compounding PDF