A PETITION FOR THE CALIFORNIA STATE BOARD OF PHARMACY TO SIGN THE FOOD & DRUG ADMINISTRATION’S MEMORANDUM OF UNDERSTANDING

TO THE MEMBERS OF THE CALIFORNIA BOARD OF PHARMACY: We seek to preserve patients’ access to pharmacy compounded medications. We demand the Board of Pharmacy to act immediately and sign onto the Food and Drug Administration's (FDA) Memorandum of Understanding (MOU) regarding the dispensing of pharmacy compounded medications.

The FDA has finalized its MOU between its agency and the Board of Pharmacy. If the Board agrees and signs the MOU, compounding pharmacies within California will be able to continue to ship prescriptions for compounded medications out of the state. If the Board chooses not to sign the MOU, compounding pharmacies within all California will be permitted to only ship 5% of all its prescriptions for compounded medications across state lines. Not signing the MOU will have disastrous consequences:

• Patients depending on specialized, compounded medications will have less options of quality compounding pharmacies to choose from.
• Consumers will lose access to customized medications as no single pharmacy makes all compounded drugs needed. Further restrictions beyond the FDA’s MOU interstate limit will only result in more compounded prescriptions unable to be filled.
• Cost of compounded medications will increase for patients and physicians, due to not being able to support as many customers.
• California compounding pharmacies run the risk of being regulated out of business.
• The MOU, if not signed, will create artificial drug shortages across many states.
• Most importantly, patients’ overall well-being and quality of care will be compromised.

As part of the Department of Consumer Affairs (DCA), we call on the Board to live up to the DCA’s mission to “…protect California consumers by providing a safe and fair marketplace through oversight, enforcement, and licensure of professions,” and the Board of Pharmacy’s Mission Statement of protecting and promoting “the health and safety of Californians.”

A decision to sign the MOU would enhance the confidence California consumers have in the DCA and Board of Pharmacy to protect their health and safety.