Congress shouldn't roll back regulations on tailored medications

In our line of work, a mistake can have grave consequences. We are pharmacists who specialize in sterile drug compounding: the creation of medications tailored to meet patient's’ clinical needs when FDA-approved products are unavailable or inappropriate.

For patients encountering specific situations such as drug shortages, allergies, or sensitivities to components of the manufactured product, compounded products can be a lifesaver, which is why we have dedicated our careers to this meaningful and fulfilling work.

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But, if compounded sterile preparations (CSPs) are not made and stored under incredibly specific quality standards, they have the potential to harm, or even kill, the patients they are supposed to help.

That is why we are alarmed to learn that Congress is considering rolling back one of the most important safeguards for patients who receive CSPs, the provision of the Drug Quality and Safety Act (DQSA) that requires facilities producing large batches of sterile compounds meet the same quality standards as conventional drug manufacturers.

DQSA establishes a clear line between traditional compounders (pharmacists, physicians, and others who can compound drugs one prescription at a time) and “outsourcing facilities” (firms that have voluntarily registered with the Food and Drug Administration (FDA) and can compound large batches of medication and distribute without a prescription). It is critical that compounded drugs are prepared under quality standards that match their level of risk to ensure their safety. Requiring a prescription for traditional compounders is a key mechanism that ensures traditional compounding pharmacies do not produce in large batches.

Contamination of compounded sterile products has resulted in numerous illnesses and deaths in the United States in recent years. The most widespread was the outbreak of fungal meningitis in 2012 that killed dozens of people nationwide and seriously injured hundreds more. The cause of that tragedy was fungal contamination of a batch of injectable medications used for pain relief.

The FDA recently issued a safety alert after receiving severe adverse event reports regarding at least 43 patients who were administered eye injections of a CSP containing triamcinolone and moxifloxacin. Both of these firms were compounding sterile products in bulk without patient prescriptions as required based on their licensing status. In both cases, patients and their families paid a terrible price for the pharmacy’s failure to comply with relevant quality standards and compounding beyond their regulatory scope.

To help prevent another widespread outbreak, Congress enacted bipartisan legislation that requires any compounding facility producing large batches of compounded sterile products and shipping via interstate commerce to comply with the same quality standards that apply to drug manufacturers.

These standards include testing every batch for sterility and potency, performing robust tests for shelf life before producing a product for sale, and rigorous monitoring of the cleanroom environment to minimize the chances of contamination. These quality standards are specifically designed to ensure safety for sterile products produced in bulk and stored for relatively long periods of time.

If the regulatory requirement for sterile compounding is weakened, compounders will once again be able to make and distribute stock supplies of sterile drugs under less stringent quality standards

Furthermore, the ability to dispense without a prescription is the benefit outsourcing facilities receive for investing in bringing their plants up to the appropriate quality standards for large batch manufacturing. And these are significant investments. For example, full sterile garb can cost more than $12,000 per person annually. A study to prove shelf life can cost more than $25,000. And, a quality assurance and control team with pharmaceutical manufacturing experience will cost hundreds of thousands of dollars annually.

By rolling back current regulations and allowing non-patient specific office-use compounding in large quantities, compounders will have no incentive to register with the FDA as an outsourcing facility voluntarily. Hospitals and other providers will be faced with sourcing compounded sterile products from facilities that likely will not meet rigorous cGMP (current Good Manufacturing Practices) standards, and patient safety will again be placed in jeopardy.

Some contend that outsourcing facilities are not making products that providers need as office stock, and thus the prescription requirement creates access issues that would be resolved by allowing office stock production under less rigorous quality standards.

If providers are experiencing difficulty sourcing certain compounded drugs, the solution isn’t to weaken the quality standards that govern how these products are produced.  Instead, stakeholders who operate in this industry should work together to ensure that compounded alternatives are widely available in the marketplace, while FDA strengthens its efforts to provide training and technical assistance to sterile compounders who may be considering becoming outsourcing facilities.

Allowing mass production of compounded sterile products without the necessary standards in place will put patient safety at risk. Congress, don’t weaken the DQSA by rolling back the prescription requirement. The safety of patients depends on it.

Greg Rockers, R.Ph., and Brian Williamson, Pharm.D.,  are Managing Directors of the Williamson Rockers Group in Kansas.


The views expressed by contributors are their own and are not the views of The Hill.