The bill on pharmacy compounding, S. 959, introduced in the Senate on Wednesday, offers no significant improvement over the draft. The American public deserves much better.
Under current law, a pharmacy that engages in large-scale, standardized drug production is considered a drug manufacturer and must obtain new drug approval from the Food and Drug Administration (FDA) to market a drug legally in the United States. In contrast, a pharmacy that engages in traditional pharmacy compounding prepares, in response to a physician’s prescription, an individually customized drug for one patient who has unique medical needs that cannot be met by a commercially available, FDA-approved drug.
Public Citizen would support legislation that clarifies the line between traditional compounding and drug manufacturing and assists the FDA in policing compounding pharmacies to ensure that they don’t engage in illegal manufacturing or other dangerous activities.
The current proposal does not clarify the line between traditional compounding and drug manufacturing. Instead, it creates a third regulatory category of “compounding manufacturers” which, contrary to current law for drug manufacturers, would not be required to seek pre-market approval from the FDA or meet some important federal labeling requirements. Rather, they would be subject to an entirely different regulatory scheme from other manufacturers. They could mass-produce new drugs without testing for safety and efficacy and would undergo
Congress should reject the HELP Committee proposal and instead adopt legislation that would:
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Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Sunday, May 19, 2013
Public Citizen to Congress: New Bill on Pharmacy Compounding a Major Step Backward for U.S. Drug Safety Statement of Dr. Michael Carome, Deputy Director, Public Citizen’s Health Research Group
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