Regulatory Focus™ > News Articles > New Compounding Legislation Borrows Heavily from FDA Framework, Will Include User Fees

New Compounding Legislation Borrows Heavily from FDA Framework, Will Include User Fees

Posted 26 April 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) would see much of its proposed plan for a national compounding framework adopted under a new plan released Friday by US legislators.


In the wake of a major compounding scandal last year, 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."

Hamburg presented what she called a "framework" for expanding FDA's regulatory authority, which calls for the segregation of compounding activities into one of two definitions: traditional compounding and non-traditional compounding.

Traditional compounding, Hamburg explained, "Would include the combining, mixing or altering of ingredients to create a customized medication for an individual patient with an individualized medical need for the compounded products, in response to a valid patient-specific prescription or order from a licensed practitioner documenting such medical need." Traditional compounding would remain under the regulatory oversight of state pharmacy boards, Hamburg said.

Non-traditional compounding would still be for a patient's medical need, but would be regulated by FDA based on the presence of one or more mitigating factors, including the compounding of sterile products, the amount of the product being made, whether the compounding is done before or after the receipt of a valid prescription, and the supply chain of the product.

Hamburg said it is her recommendation that non-traditional compounding should be required to meet CGMP standards, and that FDA be allowed to ban the production of certain types of compounds that are not safe "under any circumstances." Those products would include copies of FDA-approved drugs. Exceptions would be made for drugs experiencing shortage situations or on a case-by-case basis as FDA finds appropriate.

Hamburg said she also wanted "clear, full authority to collect and test samples of compounded drugs and production records from compounding facilities," neither of which she believed FDA currently has. Those facilities engaged in non-traditional compounding should also be required to register with FDA, she said. Other requirements, such as special labeling and adverse event reporting requirements, would be welcome as well, she added.

Congressional Response

Hamburg's plan has gotten a mixed reception in Congress, with the US Senate seemingly more amicable to her proposals that the Republican-controlled House, which has frequently maintained that FDA has sufficient authority to go after compounders and has simply been negligent in its approach.

But a new discussion draft just released by the Senate's Health, Education, Labor and Pensions HELP) Committee indicates that legislators are keen to adopt several of Hamburg's suggestions on a proposed framework.

The still-unnamed legislation was touted by one of its sponsors, Chairman Tom Harkin (D-IA), as being a "significant step forward in protecting the public from unsafe compounded products."

"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Harkin added.

"Our goal with this bill is to put an end to FDA inaction and make it clear who is on the flagpole-who is in charge and accountable for oversight of these pharmacies and manufacturers," added Ranking Member Lamar Alexander (R-TN).

Legislative Changes

The legislation contains several key points called for by Hamburg that should bolster the agency's ability to regulate compounded products more effectively.

The first element of that 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 preserve a boundary line that exists 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.

User Fees Emerge

Hamburg's idea for user fees also made its way into the draft legislation. Compounders will be required to pay an annual establishment fee meant to "defray the cost of compounding oversight," and will also be required to cover FDA's costs if a facility fails an inspection, necessitating a repeat inspection.

Also in line with FDA's framework is a ban on the compounding of any product that is "demonstrably difficult to compound," which legislators identified as being products like complex drugs or biologics, exact copies of FDA-approved drugs not undergoing a shortage, non-essential variations of FDA-approved drugs, or products that would otherwise require a risk evaluation and mitigation strategy (REMS) or other access controls. It is unclear whether sterile products might be covered under this framework. The legislation notes that the FDA Commissioner may promulgate categories or drug that are "complex dosage forms," but does not include sterility considerations specifically, though neither is it excluded either.

State boards of pharmacy will be "encouraged" to communicate with FDA, and FDA will be required to relay any information it receives regarding a complaint to other state boards of pharmacy. The idea, legislators have said, is to prevent a single compounder from having a large-scale outbreak that is spread across several states, thereby complicating efforts to keep track of adverse events.

Many of the legislation's provisions will apply to both human and animal drugs, legislators said.

HELP Committee Draft Legislation

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