Congress has Listened to Your Compounding Drug Concerns and Followed Through
I know the words ‘United States Congress’ and ‘Follow Through’ are generally never used in the same sentence, but in this case, it actually just happened! Your letters sent to Congress via our website have paid off.
On May 5, 2017, President Trump signed into law H.R. 244 after being passed by Congress, which provides appropriations through September 30, 2017. A fiscal appropriations budget is good, but the key is that this law contains language clarifying congressional intent about 503A compounding pharmacies (pharmacies like McGuff). This new law should reverse several FDA restrictions on compounding. More will be said about this when the FDA publishes a new guidance incorporating the new law. The major wins are listed below.
Draft a new memorandum of understanding (MOU) that allows pharmacies that meet all other requirements of 503A to “distribute” compounded products over state lines.
What does this mean? A 503A Compounding Pharmacy (like McGuff Compounding Pharmacy Services, Inc.) will be able to ship to all states in which it is licensed via patient prescription. This law does away with arbitrary limitations from the Federal Government on the quantity of compounded drugs shipped. The current FDA draft MOU limits distribution to 5% or 30%, depending on the approval of each state legislature. If this draft MOU was finalized in its current form, physicians and patients would not have access to the compounded drugs needed.
Draft new guidance to allow pharmacists to compound “office use” in anticipation of receiving patient-specific prescriptions later.
What does this mean? Two parts:
- Compounding Pharmacies will be allowed to compound drugs in anticipation of receiving patient-specific prescriptions.
- FDA will draft a new guidance that acknowledges compounding for office use.
We will know more about how the FDA will implement this law once a new draft guidance is created.
Pharmacies compounding under 503A shall be under the jurisdiction of the State Board of Pharmacies and are not to be held to current Good Manufacturing Practices
What does this mean? Pharmacies will follow the long-established USP standards for sterile and nonsterile compounding. The FDA was holding compounding pharmacies to Current Good Manufacturing Standards (which McGuff met and successfully demonstrated to the FDA during a seven-day inspection) that were not economically feasible and outside the intent of Congress.
I would like to personally thank you for your support in submitting letters to your congressmen. In all, physicians and patients sent 5,959 emails to Congress through our website. This is a significant number that far exceeds the number presented by several pharmacy and physician organizations. Without your direct involvement, this major victory would not be possible.
I am so excited to say the ‘system works’ based on your grassroots support. I will watch and inform you how the FDA responds to the new law. Please let me know if you have any questions.
Ron McGuff
President
McGuff Compounding Pharmacy Services, Inc.
answers@mcguff.com
Link to the Law:
https://www.congress.gov/bill/115th-congress/house-bill/244/text