Regulatory Focus™ > News Articles > FDA Hits Two Compounders for Making J&J Drug That Lacked US Approval

FDA Hits Two Compounders for Making J&J Drug That Lacked US Approval

Posted 18 March 2014 | By Alexander Gaffney, RAC

Two compounding pharmacies are the latest recipients of Warning Letters from the US Food and Drug Administration (FDA), part of a recent surge of letters reflecting the agency's new authority under the Drug Quality and Security Act (DQSA).

Background: Compounding Pharmacies and the DQSA

Unlike more traditional pharmaceutical manufacturers-think Pfizer, for example-compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique patient needs. A compounding pharmacy might make a smaller dose of a drug than is commercially available, for example.

But as a massive outbreak of fungal meningitis in late 2012 illustrated, not all was well in the compounding sector. FDA investigators would later determine that deficient quality practices at a compounding pharmacy had resulted in patients being exposed to contaminated products, leaving dozens dead and hundreds seriously injured.

A subsequent surge of FDA inspections discovered scores of similar violations at other compounding pharmacies, leading to a wave of recalls and enforcement actions.

In response to the crisis, legislators passed the DQSA, which created a new system in which some compounding pharmacies will be incentivized to register with FDA as "outsourcing pharmacies" (Section 503B of the Federal Food, Drug and Cosmetic Act) and consent to inspections. The hope, legislators said, is that this category of pharmacy will be sought after by consumers because of the quality assurances they offer relative to smaller pharmacies.

Other compounding pharmacies will continue to be regulated by state pharmacy boards (per Section 503A).

Subsequent Warning Letters

To date, FDA has only sent a handful of Warning Letters to compounding pharmacies after the passage of the DQSA.

The first letter to be sent out after the passage of the DQSA went to North Carolina-based Triangle Pharmacy, and reflected some of FDA's new authorities under the law. Specifically, it cited three new compounding guidance documents that FDA had published, and made the case that the pharmacy had violated both Section 503A and an agency Compliance Policy Guide (460.200) that were in effect at the time of the inspection.

Two subsequent letters to Nora Apothecary and Alternative Therapies and Wedgewood Village Pharmacy cited similar problems, as well as allegations that the companies had not received valid prescriptions for individually identifiable patients, had not followed current good manufacturing practices (cGMPs), and had misbranded their products.

A third letter to Pallimed Solutions, whose products were recalled in March 2013, alleged that the pharmacy manufactured adulterated products under unsanitary conditions. Unlike the previous three letters, however, it did not cite FDA's new authority under the DQSA.

Two New Warning Letters

Now FDA is out with two additional Warning Letters to Orlando, FL-based Olympia Pharmacy and Houma, LA-based Total Pharmacy Services, Inc.

As with FDA's earlier letters to Triangle, Nora and Wedgewood, the two letters specifically cite FDA's new authority under the DQSA.

In addition, one references its existing authority under a 2002 Compliance Policy Guide (CPG)(460.200).

The references to the policy guide have been controversial, as various legal decisions (Western States Medical Center v. Shalala in particular) had made it unclear if the CPG was in effect (i.e. legal) in all US jurisdictions during the time of FDA's inspections. FDA's inspection of Olympia Pharmacy occurred in March 2013 and its inspection of Total Pharmacy Services occurred in May 2013-both before the November 2013 passage of the DQSA when only the CPG would have been in effect, if it was.

FDA now claims that the passage of the DQSA "clarified that the remainder of the requirements in section 503A are applicable in every federal judicial circuit, including the requirement of valid prescriptions for individually identified patients."

The CPG has since been withdrawn by FDA, but it's still occupying prominent space in FDA's compounding Warning Letters.

Only FDA's letter to Olympia references the CPG issue. "At the time FDA inspected your facility, there were conflicting judicial decisions regarding the applicability of section 503A of the FD&C ACT, which exempts compounded drugs from several key statutory requirements if certain conditions are met," FDA wrote. "Nevertheless, receipt of valid prescriptions for individually-identified patients prior to distribution of compounded drugs was relevant for both section 503A of the FD&C ACT and the agency's Compliance Policy Guide 460.200 on Pharmacy Compounding (CPG) (2002), which was then in effect."

The firm was observed to have compounded "a portion" of its medicines without having first received valid prescriptions for individually-identified patients. FDA said "this factor alone" caused the products to not meet the legal requirements for compounded products.

An Unapproved Compounded Product

Interestingly, both Warning Letters also cite a common drug ingredient: domperidone.

The drug, marketed abroad as Motilium, is designed to block dopamine receptors, and was originally developed by J&J subsidiary Janssen Pharmaceuticals. However, it is not approved in the US.

In its Warning Letters, FDA said that because domperidone is not approved, neither company was legally permitted to compound it under Section 503A of the FD&C Act.

Accordingly, both companies were chided by FDA for misbranding violations for marketing unapproved products.

Both companies were also accused of adulteration for compounding their products under "insanitary conditions."

The companies were given 15 days to comply with FDA's Warning Letters.


Olympia Pharmacy

Total Pharmacy Services, Inc.

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