Members of DQSA Coalition and State Pharmacy Associations Send Letter to State Boards of Pharmacy & Medicine
The DQSA Coalition, a broad cross-section of organizations representing varied healthcare providers, state pharmacy associations, pharmacists and patients, sent a letter to all state Boards of Pharmacy and Medicine, expressing continued concern regarding the Food & Drug Administration's (FDA) implementation of the Drug Quality & Security Act (DQSA) without following Congressional intent. The letter emphasized that FDA's actions consequently are affecting patient access to compounded medications, and causing mass confusion for the States, providers, patients, and pharmacists.
The letter also urged Board members to delay consideration of any regulatory or policy decisions on the ability of practitioners to obtain and use office-use compounded preparations until such time as FDA issues guidance in a manner consistent with Congressional intent, and which preserves patient access to vital, life-saving medications. Patient access to compounded medications is a patient safety issue.
From the Letter: Our organizations represent physicians, pharmacists, other healthcare providers, surgical centers, and patient advocates treating and providing care to patients with an array of conditions requiring a broad spectrum of treatments and also pharmacists that provide physicians, hospitals, and other health care professionals with compounded medications for administration to and treatment of patients within these practice settings (often called "office-use"). As such, we have been closely monitoring the Food and Drug Administration's (FDA) implementation of the Drug Quality and Security Act ("DQSA", P.L. 113-54) and remain concerned about the impact of the Agency's actions on patient access to compounded medications and the mass confusion amongst the States that has resulted.
Specifically, we remain deeply concerned about the FDA implementation of the DQSA in regard to both compounded and repackaged medications for office-use. Every day, compounding pharmacists serve patients in a variety of areas including: autism, oncology, dermatology and pediatrics. Compounding pharmacists also have served patients such as pre-term infants who require parenteral nutrition (PN). PN provides intravenous life-saving therapy for patients whose gastrointestinal (GI) tracts are not functioning or cannot be accessed or where nutritional needs cannot be met with oral or enteral diets. These are just a few examples of how compounding pharmacists are working with physicians to provide life-saving medications for patients.
Our organizations urge the members of your Board to delay consideration of any regulatory or policy decisions on the ability of practitioners to obtain and use office-use compounded preparations until such time as the Agency issues its guidance in a manner that is consistent with Congressional intent and that preserves patient access.
About the DQSA Coalition:
The International Academy of Compounding Pharmacists (IACP) was instrumental in creating the DQSA Coalition and has led this broad provider and pharmacy organization with a primary goal of ensuring the FDA implements the Drug Quality & Security Act as Congress fully intended.
