FDA Wants New Regulations to Target Compounding Pharmacies

Last week, two warnings sent by the US Food and Drug Administration (FDA) regarding potential infections and contaminations in compounded drugs led to Margaret Hamburg​, Commissioner of the FDA, admitting the FDA’s “authorities are limited and not the right fit”​ to regulate the growing compounding pharmacy industry.

“Over the past two months, we have inspected over 30 facilities,”​ she said, though acknowledged some “inspectors are being delayed in their work or denied full access to records at some of the facilities”​

She continued, adding: “I firmly believe that new legislation is necessary to help FDA effectively oversee firms engaged in widespread distribution of sterile compounded drug products in advance of or without receiving a prescription.”​

Hamburg’s comments came after Connecticut Senator Richard Blumenthal stated his concerns in an open letter to the FDA​ regarding the latest spate of safety issues: “It reflects that the compounding pharmacy industry has been operating without effective oversight and scrutiny as a result of gaps in current laws and FDA regulation.”​

Avastin​

Recent recalls include a potential mould contamination in a compounded magnesium sulfate intravenous solution, compounded by Med Prep Consulting​ and Avastin, recalled by compounding pharmacist Clinical Specialties after the FDA received reports of five intra-ocular infections from physician’s office.

Avastin is licensed and sold as a cancer treatment by Genentech – bought by Roche​ in 2009 for $47bn – and, according to spokesman Terry Hurley, “has not been proven safe for use in the eye.”​

Companies like Clinical Specialties take large vials of Avastin and divide them into smaller doses, package them and supply them as single-use vials for injection into the eye. US physicians use the drug as an unofficial therapy for age-related macular degeneration in place of Lucentis, a more expensive official drug also marketed by Roche

Hurley told in-Pharmatechnologist.com: “The practice of compounding medicines such as Avastin for intravitreal use in the pharmacy has been associated with a risk of contamination and subsequent infection and inflammation.”​

He continued, explaining that compounded drugs could lead to a number of problems including “microbial or particulate contamination”​ or “incorrect dosing calculations”​ because of “improper or inadequate handling procedures.”​

FDA and Compounding Pharmacies​

Avastin was at the centre of another compounding quality issue in August 2011​ in the State of Florida. A study in the American Journal of Opthalmology​ attributed potential causes of vision loss on poor aseptic technique at compounding pharmacies.

The researchers cited the “dissolution of the FDA’s Pharmacy Compounding Advisory Committee”​ as a major contributor to the “breaches in the enforcement of quality standards for compounding pharmacies.”​

In the 1990s the FDA had powers to identify threats to efficacy and safety of compounded drugs yet these were removed in 2001 by the US Supreme Court who ruled them unconstitutional.

Hamburg said the “FDA is working with Congress, states, industry, and all interested stakeholders to develop a basic framework to protect public health.”​ She high-lighted that all compounding pharmacies should be subject to:

• clearer authority to examine a pharmacy’s records in order to more quickly locate the cause of an outbreak or other violations of the law
• the prohibition of compounding the most complex and highest risk products

Europe​

In-Pharmatechnologist.com asked the European Medicines Agency (EMA) how prevalent compounding pharmacies are in Europe and if it they fell under any specific regulations.

“We do know that compounding pharmacies do exist in the EU,”​ said David Cockburn, Head of Manufacturing and Quality Compliance. “Although administrative approaches for regulating them do differ, the tendency is for Member States to require adherence to GMP for activities that approach industrial manufacturing scale.”​