We are deeply concerned with the Boards consideration of prohibiting nonsterile and sterile office-use compounding, and strongly disagree with the assertion that this change in policy is necessary to comply with federal law. Congress has been very clear that nothing within the DQSA prohibits office-use compounding and that office-use compounding shall remain regulated by States. Recent implementation actions by the FDA and the information being provided by the Agency to States have caused confusion amongst State boards of medicine and pharmacy and have adversely impacted practitioner and patient access to vital medications.

Many medical professionals and healthcare facilities rely on various types of compounded medications to treat their patients -- whether it is in their office, on a crash cart in an emergency department, or in another medical setting. These medications are essential for emergency situations as well as to initiate treatment immediately in response to a medical condition. Medications are compounded in order to meet specific dosage needs and are critical to the timely treatment of many patients when a prescriber determines that a FDA-approved drug product is neither available nor appropriate to treat their condition and achieve the best possible therapeutic outcome.