Regulatory Focus™ > News Articles > Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements

Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements

Posted 02 May 2013 | By Alexander Gaffney, RAC

A US Senate proposal to overhaul the way in which compounded pharmaceutical products are regulated is being slammed by a prominent public advocacy group, Public Citizen, which claims that the proposed legislation is "a major step backward for US drug safety."


In the US, pharmaceutical products generally fall into two categories: Those that are manufactured, typically for use by a wide audience, and those that are specifically tailored for a specific individual in response to a doctor's order, better known as compounded drugs.

The latter have recently been the subject of a huge amount of state and federal scrutiny after a series of safety problems resulted in a single drug killing more than 50 people across the US and injuring hundreds more.

In the wake of that scandal, FDA's Margaret Hamburg issued a new proposal that she said was geared toward making sure that compounded products manufactured in the US are safe and effective and-critically-manufactured to appropriate standards.

"FDA believes that there is a legitimate role for traditional compounding to provide needed drugs to patients that, for example, need a drug that is allergen-free or have a medical need that cannot be met with an approved FDA product," explained Hamburg in testimony before the US House of Representatives in November 2012. "However, we have grown increasingly concerned about certain compounding practices, and we have seen an increasing number of incidents related to compounded drugs. The New England Compounding Center (NECC)/meningitis situation is the latest, and most serious, incident."

The Senate Proposal

Hamburg's proposal was largely picked up by Senate legislators in their recently released draft of their compounding legislation, but also a few that are entirely new.

The first element of the framework is perhaps the simplest: FDA will now have the authority to treat compounded products as a "new drug" under the Federal Food, Drug, and Cosmetic Act (FD&C Act), allowing the agency to exercise considerably more authority over compounded drugs.

However, legislators said the legislation would still create a new boundary line between so-called "traditional" compounders and those that operate as "compounding manufacturers". A national system of oversight would be in place for the latter, while states would continue to oversee the "traditional" compounders that make single, non-sterile products for use only after receiving a prescription from a physician. The latter are defined as those manufacturing products in advance of receiving a prescription.

"Any entity that pools sterile products, or that repackages sterile, single-use, preservative-free vials is also a compounding manufacturer. In order to maintain clear accountability, compounding manufacturers cannot be licensed as pharmacies," legislators said in an explanatory piece accompanying the legislation.

Pharmacies would also need to register with FDA and inform the agency of what products are manufactured at the covered facility. Companies would also be required to meet good manufacturing practice standards, report and investigate adverse event reports, and label products to indicate that they are compounded (rather than manufactured) products.

Public Citizen Blasts Draft Proposal

But the language of that draft legislation was concerning, if not confusing, to Public Citizen. The group pointed to the "compounding manufacturer," noting that this distinction would create an entirely new category of manufacturers. The group explained that this contrasts sharply with traditional compounding, which is meant to be in response to a single prescription and for a single patient.

"These second-tier manufacturers would be permitted to mass-produce standardized drugs and sell across state lines without obtaining FDA approval or meeting federal labeling requirements intended to ensure the safe use of drugs - requirements currently mandated for all drug manufacturers," Public Citizen said.

And that's problematic, the group said, because under the new system, some manufacturers would see an incentive to skip FDA's regulatory processes entirely and go into large-scale compounding.

"Under these clearly weakened standards, "compounding manufacturers" … could mass-produce new drugs without obtaining FDA premarket approval or complying with federal labeling requirements," the group continued. "As a result, 'compounding manufacturers' could manufacture new drug formulations and combinations that have not been evaluated for safety and efficacy and could launch new, untested manufacturing processes without first receiving an inspection or approval by the FDA. They also would not be required to include labels that explain how to safely use the product, including indications for use, precautions and warnings about serious toxicities, and contraindications for use."

Public Citizen goes on to call for the rejection of the Senate's draft framework in favor of a new one that uses a two-category litmus test: Either a drugmaker is a traditional manufacturer, or it is a compounder. Its proposed framework would also give FDA new authority to go after compounding pharmacies and conduct inspections.

Public Citizen Statement on Senate HELP Committee Draft

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