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
Friday, December 13, 2013
The Myths and Truths of the Bill on Drug Compounding
API traders and importers may place a different spin on the DQSA--one stakeholder's myth is another stakeholder's truth (hopefully).
For 503B's, the House investigation shows that FDA had previously characterized firms like NECC and Ameridose as non-traditional outsourcers, because they bypassed acquisition of FDA-approved products in the production of hospital admixtures. DQSA restores outsourcing to this traditional role, while providing a mechanism to source API-produced compounds produced under GMPs during shortages or for other public health needs vetted by the FDA.
State oversight of pharmacy practice (including compounding) differs from federal oversight of the safety, efficacy and quality of drugs. They are equally important, but not interchangeable. Any compounded drug can come under federal oversight if conditions for exemptions under the Food and Drug act are not met. This should be common sense--tension exists where the intent is to exploit the exemptions and engage in systematic or large-scale substitution compounding (manufacturing under the guise).
It's important to note that the legal framework for compounding medications may change over time, and regulations may vary by jurisdiction. Healthcare professionals, including pharmacists, are expected to stay informed about current laws and guidelines to ensure compliance and patient safety. If you have specific questions or concerns about compounding medications, it's advisable to consult with legal and regulatory authorities or healthcare professionals familiar with the laws in your region.FDA Lawyers
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API traders and importers may place a different spin on the DQSA--one stakeholder's myth is another stakeholder's truth (hopefully).
For 503B's, the House investigation shows that FDA had previously characterized firms like NECC and Ameridose as non-traditional outsourcers, because they bypassed acquisition of FDA-approved products in the production of hospital admixtures. DQSA restores outsourcing to this traditional role, while providing a mechanism to source API-produced compounds produced under GMPs during shortages or for other public health needs vetted by the FDA.
State oversight of pharmacy practice (including compounding) differs from federal oversight of the safety, efficacy and quality of drugs. They are equally important, but not interchangeable.
Any compounded drug can come under federal oversight if conditions for exemptions under the Food and Drug act are not met. This should be common sense--tension exists where the intent is to exploit the exemptions and engage in systematic or large-scale substitution compounding (manufacturing under the guise).
It's important to note that the legal framework for compounding medications may change over time, and regulations may vary by jurisdiction. Healthcare professionals, including pharmacists, are expected to stay informed about current laws and guidelines to ensure compliance and patient safety. If you have specific questions or concerns about compounding medications, it's advisable to consult with legal and regulatory authorities or healthcare professionals familiar with the laws in your region.FDA Lawyers
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