Compounding quality concerns: Legislation could 'fundamentally undermine' patient protections

By Melissa Fassbender

- Last updated on GMT

Letters have been sent to the Appropriations Committees of the US Senate and the US House of Representatives, as well as to the US Food and Drug Administration (FDA) Commissioner. (Image: iStock/AlexRaths)
Letters have been sent to the Appropriations Committees of the US Senate and the US House of Representatives, as well as to the US Food and Drug Administration (FDA) Commissioner. (Image: iStock/AlexRaths)

Related tags Pharmacy Pharmacology

Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).

The Pew Charitable Trusts, in collaboration with the Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), and other industry stakeholders and public health organizations, has sent a letter​ to House and Senate appropriators.

The letters are a reaction to recent discussion in the appropriations committee in which there has been report language and a proposed amendment that would break down the line between traditional drug compounders and outsourcing facilities, Elizabeth Jungman, director, Public Health Programs, The Pew Charitable Trusts, told

Compounding concerns

Pew’s drug safety project​ identified more than 50 reported compounding errors or potential errors associated with 1,227 adverse events from 2001 to 2017 – including 99 deaths.

Legislation that would allow traditional compounders to make stock supplies of drugs without adhering to appropriate quality standards would fundamentally undermine the patient protections Congress put into place in 2013​,” Jungman explained.

Creating a new category of outsourcing facilities

Prior to 2013, when the Drug Quality and Security Act (DQSA) was passed, Jungman said there was confusion about whether compounding by traditional state-regulated pharmacies had to be patient specific​.

Part of that is because the law that requires [patient-specific compounding at pharmacies], section 503A, which was passed in 1997, was immediately challenged in court and there were conflicting court decision about it​,” she explained. “So the legal status of 503A was very uncertain and FDA did not enforce it for a long time​.”

A multistate outbreak of fungal meningitis

In 2012, 64 people died and more than 800 fell ill during a fungal meningitis outbreak​ linked to contaminated steroid injections at the New England Compounding Center.

In response to the tragedy, Congress enacted Title I of the 2013 Drug Quality and Security Act (DQSA​) in 2013. The Act provides the FDA with more authority to regulate compound drug manufacturing.

The law created a differentiation between compounding pharmacies and outsourcing facilities, which are now regulated, respectively, under section 503A and 503B of the United States Federal Food, Drug, and Cosmetic Act (FFDCA).

Last month, Barry Cadden, co-founder and former president of the center, was sentenced​ to nine years in prison for his role in the multistate fungal meningitis outbreak.

However, in 2013 Congress made changes that clarified the legal status of section 503A – now it’s clearly the “law of the land​” and FDA enforced, said Jungman.

The changes created a new category of outsourcing facilities through section 503B (see sidebar).

Undermining the law

One of the most controversial aspects lately, has really been this line between what type of activity can happen at a traditional compounder – which is primarily regulated by the state – as opposed to what really needs to take place in an outsourcing facility that is subject to federal regulation​,” said Jungman.

It’s important to draw that line very clearly​,” she added.

It is the potential blurring of this line that has spurred several stakeholders to raise concerns with the US House of Representatives and Congress, as well as the US Food and Drug Administration (FDA).

Jungman said it is also in the interest of outsourcing facilities for FDA to continue to robustly implement the prescription requirement​ and for Congress to maintain it. “If that doesn’t happen, then facilities that have not made the investment that the outsourcing facilities have made in coming up to good manufacturing practices would be able to operate under a similar business model​,” she explained.

The prescription requirement under section 503A was designed to distinguish compounding by a licensed pharmacist or licensed physician from conventional manufacturing.

Ultimately the business model for outsourcing doesn’t work if traditional compounders can create the same types of products in the same way under quality standards that are not designed for that type of compounding,” ​Jungman said.

It’s really important to make sure [compounding] happens under the quality conditions that are appropriate, so that you prevent the kind of tragedy that led us to the law in the first place​.”

A letter to Commissioner Gottlieb

In response to these same concerns, BIO, PhRMA, and 22 state biopharma organizations also sent a letter to FDA Commissioner, Scott Gottlieb, M.D.

The letter communicates concerns regarding the attempts to weaken federal oversight of compounded drugs and urges the FDA “to maintain the final guidance issued in December 2016 and to resist any changes that would jeopardize patient safety​.”

Patients’ access to medicines which need compounding is an incredibly important issue. Equally important is ensuring pharmacy compounding facilities meet strong quality and safety requirements by the U.S. Food and Drug Administration (FDA) as part of the Drug Quality and Security Act​,” Andrew Powaleny, director of public affairs at PhRMA, told

The FDA has said their efforts are part of their ‘commitment to doing all we can to protect the public from poorly compounded drugs’ and we believe that to protect patient safety the Agency must continue to have the authority to conduct rigorous oversight and maintain a clear distinction between pharmacy compounding and outsourcing facilities​.”

According to the letter, as of June 2017, only 72 compounding operations had registered​ with the FDA as outsourcing facilities.

There is reason to believe that a substantial number of purported 503A compounding pharmacies should be registered as 503B outsourcing facilities but have evaded their responsibilities​,” the letter explained.

In fact, in a July 2016 notice, the FDA stated: “Our experience was that in the substantial majority of cases, inspected human drug compounders not registered as outsourcing facilities were compounding at least some of their drugs not in accordance with Section 503A​.”

Subsequently, the letter encourages increased inspection levels.

An FDA representative told us the agency has received the letter and will respond directly to the signatories. 

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