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.
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.
Anonymous said...
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).
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).