Your access to compounded medications is once again at risk because of the Food and Drug Administration (FDA). Help us protect your rights and add your comments to those of physicians and patients nationwide who are telling FDA to play by the rules Congress has set to protect your access to the compounded medications you need.
Here are the facts:
- Recently, Congress passed the Drug Quality and Security Act. That new law gave FDA the authority to regulate interstate distribution of compounded medications.
- If the FDA gets its way, if a pharmacy in another state dispenses your personal prescription, it could be redefined as interstate distribution. And, according to the terms of a “Memorandum of Understanding” the FDA wants your state to sign, your access to compounded medications would be severely limited in a random, unpredictable way.
- By trying to take control of interstate dispensing, the FDA is telling you that you can’t get necessary medications because you don’t live in the same state as the pharmacy you have chosen.
- Many compounding pharmacies dispense unique preparations that require a high level of expertise to compound. Their pharmacists and staff undergo extensive training and pursue continuing education in their specialties. They provide medications to prescribers and patients across the country that most pharmacies aren’t equipped or can’t afford to make for small, local markets. They rightfully have earned national reputations and the trust of many patients, their families and physicians.
Here’s what you can do:
Tell the FDA to play by the rules Congress has set. Protect your right to choose where and when you fill your prescription for compounded drugs. Go to Regulations.gov and give your opinion about FDA’s proposed limitations to your right to use compounded medicine. Use your own words to let the FDA know how you’d be affected if your access to your compounded medications were suddenly and randomly shut off. Here’s the kind of comment that can make a huge difference:
“My health depends on compounded medications. [Insert a personal example about the difference compounded medications make to you and your family.] I strongly object to the FDA proposal to regulate dispensing of compounded medicines. This FDA action would take away my choice of compounding pharmacies, punish reputable pharmacies that are providing high-quality medications and make access to my medicine unpredictable. The FDA should not put my prescription at risk. There should be no arbitrary or artificial limits set on interstate dispensing of compounded medications to individual patients who have a prescription.”