GGVCP Sterile and Non-Sterile Preparations

On June 2nd and July 12th the California State Board of Pharmacy Enforcement and Compounding Committee met to discuss many on-going and some highly debated regulations. We are happy to pass along that on July 25th the Full Board voted to approve emergency regulation changes to bring non-sterile beyond use date regulations in line with USP 795. This will no longer require the same level of testing for non-sterile preparations as is required for sterile preparations. We will be able to continue to reference published formulas when determining non-sterile beyond use dating. In addition, we will be able to extend BUDs with justification where published studies are lacking (i.e. testing combined with clinical and pharmaceutical analysis of the formulation). We are thrilled that we will be able to continue to provide all of the non-sterile compounds that your patients need with a shelf life conducive to normal administration.

Unfortunately, not all updates were as thrilling. The Board has voted to postpone any similar updates when it comes to sterile compounding. As it stands now, in order to extend a BUD for a sterile compound, a pharmacy must conduct sterility and stability testing on par with drug manufacturers that will cost anywhere from $10,000 - $50,000 per formulation. This type of testing is not feasible for most compounding pharmacies, Golden Gate VCP included. To justify these expenses, we would either have to significantly raise prices or discontinue products that do not meet the Board’s requirements. Neither option is appealing. However, since the Board has chosen not to further address these regulations at this time, we have no choice but to discontinue the sterile products that do not meet the testing requirements. The discontinued medications are as follows: Desmopressin drops, Methocarbamol injections, Praziquantel injections, Prednisolone Acetate injections, Prednisone injections and Triamcinolone injections. We apologize for the inconvenience that this may have on you and your patients. We are hopeful that the Board will re-address this issue and come to a decision that is realistic for pharmacies, patients and prescribers, while maintaining medication quality and most importantly, consumer safety. We will continue to compound sterile products that we already have complete testing on and that have published stability indicating studies supporting their BUDs. These medications include; Apomorphine, Cidofovir, Cyclosporine drops and ointment, Idoxuridine drops, etc.

We will continue to keep you updated on any and all California State Board of Pharmacy (and any other) regulations that affect you and your clinics. We also encourage you to write to the Board of Pharmacy and let them know how the changes they have enacted are affecting the treatment of your patients. Any correspondence with the Board can and should focus on the impact to patient care. If you are interested in the Board hearing your concerns, you may send any correspondence to the following address:

California Board of Pharmacy

Attn: Enforcement and Compounding Sub-Committee Chair Person

1625 N. Market Blvd., Suite N219

Sacramento, CA 95834