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FDA Compliance for Compounding Pharmacies and Outsourcing Facilities

Compounding PharmacyThe Drug Quality and Security Act (DQSA), legislation contains important provisions relating to the oversight of compounding of human drugs.  It allows compounding pharmacies to register as an outsourcing facility or operate as a compounding pharmacy; however, regardless of registration, all drugs must be compounded under sanitary conditions (current good manufacturing practice or cGMP). FDA inspections of compounding pharmacies and outsourcing facilities have increased in the past year. Many FDA 483 observations and warning letters have been issued, mandatory recalls and production shutdowns have been decreed and even criminal charges have been levied for non-compliant parties.

The FDA intends to continue proactive and for-cause inspections of compounding pharmacies, and plans to take aggressive action, including enforcement actions.  

PharmaSys can help compounding pharmacies and outsourcing facilities interpret and comply with FDA regulations as well as respond to and remediate enforcement

Click here to see how PharmaSys can help you.

Since 1998, PharmaSys has completed over 2000 engagements with no 483 or warning letter observations. Our record speaks for itself!


PharmaSys can help you Comply with FDA Regulations for Compounding Pharmacies and Outsourcing Facilities
FDA Compounding Pharmacy and outsourcing facility compliance information
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