Legislation FAQs

My compounder is a traditional (503A) compounding pharmacy – what does this mean?

A 503A pharmacy practices the traditional art and science of compounding. That is to say, they will create individual doses for individually identified patients that require – based upon the physician’s judgment – something that is not available in an FDA approved format. Advance prescriptions with individually identified patients are required for each and every dose. Similarly, they may not create something that is an essential copy of an FDA approved medication. Drugs produced by these compounding pharmacies are not FDA approved nor are the processes under which they are made subject to FDA oversight.

How can I check if my compounder has been inspected by the FDA?

Please follow the link to the FDA’s website for the most current list of inspections.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm

My compounder is a 503B – what does this mean?

503B is a voluntary designation by which facilities agree to adhere to strict, cGMP (FDA regulated) manufacturing parameters, not make copies of FDA approved drugs, and producing to a specific list of required substances. In return, these facilities are permitted to manufacture and distribute selected drugs without prescriptions.

Is Mitosol USP 800 compliant?

Yes,  Mitosol is already packaged with a closed system transfer device and conforms to the regulations.

What is USP 800?

USP 800 is an extension of the USP 797 guidelines stating that necessary precautions must be taken by healthcare workers to prevent unwanted exposure to hazardous drugs, all the way to the point of patient administration.  Of most relevance to the ophthalmic OR, USP 800 will require the use of closed system transfer devices when handling mitomycin-c.

What is DQSA and how does this impact my facility?

DQSA (the Drug Quality and Security Act) is a law that was passed following the New England Compounding Center tragedies to establish oversight of compounding pharmacies.  The law was the first step to ensuring compounders are held to a higher standard, not making copies of FDA approved drugs, and more specifically will establish a list of active pharmaceutical ingredients approved to be compounded.  We have a recent DQSA Webinar posted on site, if you’d like to learn more.