SOURCE: Xtalks

Xtalks Webinars

December 07, 2015 15:00 ET

Top 2 FDA Issues Affecting Compounding Pharmacies and Outsourcing Facilities, According to Xtalks

TORONTO, ON--(Marketwired - December 07, 2015) - Compounding pharmacies perform the necessary role of preparing prescription medications on a patient-by-patient basis in customized formulations, to ensure the drug can be administered to -- and tolerated by -- the individual. Pharmacists who specialize in compounding ingredients are capable of personalizing medications in a variety of ways; the compounder can change the form of a medication (for example, from a solid pill to a liquid), remove non-essential ingredients from medications to accommodate someone with an allergy, or add a flavouring to a liquid medication in order to increase the palatability of the drug for a child.

Historically, compounding pharmacies have been free from US Food and Drug Administration (FDA) oversight, and were instead regulated at a state level in much the same way as other pharmacies. In 2013, following the death of 63 patients from meningitis which was traced back to a compounding pharmacy, the government agency signed the Drug Quality and Security Act (DQSA) into law, under section 503B of the Food, Drug & Cosmetic (FD&C) Act, in an effort to better regulate compounding pharmacies.

The new law outlined an increase in FDA oversight of so-called 'non-traditional' compounding facilities -- also known as outsourcing facilities. The main distinction between a compounding pharmacy and an outsourcing facility is that the compounded drugs may or may not be made in response to a specific patient's prescription. An outsourcing facility can distribute their products out of state and may choose to produce specialized medicines in larger quantities compared to compounding pharmacies, in anticipation of future orders.

Currently, registering as an outsourcing facility with the FDA is a voluntary process which costs tens of thousands of dollars in annual fees. Registration also exposes a facility to federal oversight, including inspections and imposed compliance with regulations. Despite these perceived negatives, once an organization is registered as an outsourcing facility they are eligible for certain drug-approval exemptions, of which large-scale pharmaceutical manufacturers are subjected.

While the FDA has issued guidance on what types of compounding facilities should register under section 503B, many compounding pharmacies are unsure of whether their organization is eligible for exemptions and if those benefits would outweigh the FDA scrutiny. Still other compounders have registered with the agency, but are struggling to comply with stricter regulations.

Regardless of the current status of any compounding pharmacy, the following are the top two issues currently affecting professionals in the industry today. If you'd like to learn more about the FDA's expectations for 503B-registered outsourcing facilities, register for the upcoming webinar where speaker Doyle Smith, a Compliance Specialist with Compliance Insight Inc., will be helping compounding pharmacy owners and operators solve their top issues. Take the Xtalks Compounding Pharmacy Quiz to determine if your pharmacy might qualify to register as an outsourcing facility! --

To read more on the article on 503B Registration Filing and FDA 483/Warning Letter, click here:

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