Note: Following information is from College Pharmacy, a fully licensed compounding pharmacy.
Why Is The FDAs MOU A Threat To Your Access To Compounding Pharmacies and Compounded Medications?
The FDA Memorandum of Understanding (MOU) is a guidance document that was created by the FDA to explain the regulatory framework that it plans to use in enforcing the Drug Quality and Security Act that was passed in November 2013.
In the current draft form, the MOU would regulate the interstate filling of compounded prescriptions by 503(a) compounding pharmacies. As the majority of compounding pharmacies in the U.S. are 503(a) compounding facilities, the impact would be one felt throughout the nation by patient and practitioner alike.
IMPORTANT Deadline: July 20, 2015 at 11:59pm
Unprecedented Expansion of FDA Oversight
The intent of the original MOU was to prevent compounding pharmacies from becoming manufacturers and limited office use prescriptions. The FDA has since taken that intent and expanded it into unprecedented areas of oversight and regulation to include interstate commerce.
The current draft MOU would restrict compounding pharmacies to no more than 5% of interstate sales per month unless their respective state agrees to enter into a MOU agreement with the FDA. If the state agrees to bear the burden for any adverse events or quality issues, then those pharmacies may increase their interstate sales to 30%.
This is supposed to translate into patient safety. So, 5% interstate sales per month is safe. 30% interstate sales per month is only safe if a state bears the burden of adverse events. 35% of interstate sales is not safe and shall not be allowed. The proposed regulation of interstate commerce has no scientific or evidence basis. These are arbitrary numbers with no tie to patient safety.
The MOU would leave state boards of pharmacy with an unfunded mandate to investigate and report pharmacies in violation of the FDA’s interpretation of federal law. It would place significant economic burdens on a state without providing appropriate funds for required reporting activities. There is no benefit to the state to enter into the MOU.
The MOU would reduce patient access to medically necessary treatments, restrict interstate commerce, and punish successful pharmacies that already adhere to all existing state and federal regulations.
We take exception to the FDA’s expansion of oversight, not because we are a compounding pharmacy that ships throughout the U.S., but because as citizens we believe in the right of choice and access and that the following points should be part of the discussion now before the MOU is adopted:
- The Right to Choose: Every patient and practitioner should have the right to choose the compounding pharmacy of their choice.Compounding pharmacies are not interchangeable. Patients should have the right to easily access compounded medications from a compounding pharmacy in another state. They currently do. And the DRAFT MOU does not lend itself to an increase in patient safety by regulating interstate commerce.
- As mentioned above, compounding pharmacies are not interchangeable. The MOU would severely restrict patient access to and choice of compounding pharmacies offering the services that they require. While most compounding pharmacies can produce capsules and topical preparations, specialty dosage forms and sterile compounds often come from pharmacies throughout the U.S. that are expertly trained to meet the compounding needs of specific patient groups. For instance: Are you a current patient or practitioner that uses our sublingual tablets or fused pellet implants? If you are outside of Colorado, your access will be severely limited.
- Doors will close. If a compounding pharmacy is currently shipping out more than 30% of monthly sales through interstate channels, it does not mean they are participating in illegal manufacturing practices. It means that patient and practitioner alike have chosen to do business with them because of expertise, because of specialty compounding services, because of exclusive formulations…because it is a free-market and they have the right to do so. It is the law abiding, experienced, comprehensive compounding pharmacies that will feel the brunt of the MOU if it is adopted in the current form. Why? Supply and demand. While there is a demand nationwide that keeps our doors open, that same demand does not exist in a single state.
IMPORTANT Deadline: July 20, 2015 at 11:59pm
We put patient safety above all else. The MOU fails to increase patient safety and would severely regulate compounding pharmacies to the point of scaling back services and closing doors.
There should be no limit to the interstate shipping of prescriptions as long as 503(a) compounding pharmacies follow both state and federal regulations.
It is not just about keeping our doors open. It is about keeping an industry alive. It is about ensuring that patients and practitioners have access to the integral services that compounding pharmacies provide.
Read the entire message from CollegePharmacy.com