The Senate will soon vote on a bill that could seriously restrict patients (including newborns & spectrum disorder/Autistic children), prescribers, pet owners, hospices, hospitals from access to personalized, compounded medications on which they depend for health and quality of life. The bill has implications for everyone, but it especially affects medications for: Hormone Replenishment (BHRT); Chronic pain management; Autism Spectrum Disorder; and Pets. The language of the bill is so broad it may transform ALL compounded medications into New Drugs (according to the FDA) and New Drug Applications cost millions of dollars and years-to-decades to submit, test and fulfill. Compounding is an ages-old pharmacy practice where a pharmacist receives a prescription from a prescriber and fills that prescription for one patient. The FDA was developed to monitor and regulate MANUFACTURERS (many dosage forms, no individual prescriptions, many anonymous 'patients'/consumers). This is a critical distinction that may be lost in the wording of the bill.
Please vote NO on S. 959. We all agree that manufacturers that pose as compounding pharmacies should be regulated and monitored by the FDA. In fact, the FDA KNEW about the NECC manufacturer some 9 years BEFORE they manufactured and sold contaminated steroid spinal injections and caused the tragic illnesses and deaths all over this country.
NO on S. 959: Pharmaceutical Compounding Quality
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