News & Events

FDA Statement

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

For Immediate Release

September 25, 2018

Statement

Good morning and welcome. I am Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis here at the Food and Drug Administration.

I would like to thank you all for traveling from near and far to be with us today to participate in our seventh intergovernmental meeting on drug compounding. Wherever you hail from, and whether this is your first or seventh meeting, we’re glad to have you join us to continue our ongoing dialogue about ways to reduce the risks associated with compounded drug products and improve collaboration between FDA and the states. We greatly value our work with you, and we feel strongly that our partnerships with you are critical to maintaining robust oversight of compounders to protect the public health.

As we all know, compounding can play an important role in patient care, but because compounded drug products are not reviewed by FDA for safety, effectiveness, or quality before they are marketed, they should be used only when necessary to meet patients’ medical needs. Federal law contains important provisions applicable to compounded drugs.

During this meeting, we look forward to continuing our ongoing dialogue about appropriate oversight—including inspections and enforcement—of compounders. Unfortunately, FDA continues to see concerning conditions during our inspections and learn of serious adverse events associated with compounded drugs. Since the 2012 outbreak of fungal meningitis, we have overseen more than 200 recalls conducted by compounders, most as a result of FDA inspectional findings indicating lack of sterility assurance. We value the many instances in which we have partnered with states to address emerging risks that present a danger to public health, and we look forward to discussing ways to increase such collaboration moving forward.

Implementing federal law on compounding continues to be a high priority for the agency. Earlier this year, FDA released a 2018 Compounding Policy Priorities Plan, describing key initiatives to implement federal law and advance our public health mission. We have made significant progress this year, including our recent announcement regarding the revised draft FDA-state memorandum of understanding—or MOU—addressing certain distributions of compounded drug products. I echo Commissioner Gottlieb’s statement that an important goal of the MOU is to further our collaboration with you so that, working together, we can have the greatest public health impact while also maximizing our resources.

I’m pleased to announce that today, FDA is releasing three new important policy documents related to compounding:

  1. Revised Draft Guidance: Insanitary Conditions at Compounding Facilities
  2. Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities
  3. Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities

I’ll start with describing FDA’s revised draft guidance on insanitary conditions.

As many of you know, FDA frequently identifies insanitary conditions during its inspections of compounding facilities, such as vermin, insects, and microbial growth in areas where drugs required to be sterile are produced. Federal law prohibits the production of drugs under insanitary conditions. Drugs produced under insanitary conditions have led to outbreaks of infections and deaths resulting from contaminated drugs, including the 2012 fungal meningitis outbreak that I spoke of earlier. Shortly after that outbreak, FDA convened the first set of these intergovernmental meetings during which the states urged FDA to issue a guidance describing real world examples of insanitary conditions that it had observed, and today we are taking another important step in fulfilling that request.

Let me share some actual examples of conditions that FDA has observed:

  • Dead spiders, beetles, ants, wasps and cockroaches in a ceiling panel directly above the area where employees prepare for sterile processing
  • Dog beds, dog fences, and dog hairs within a compounding facility, including in close proximity to the compounding room
  • Operators processing sterile drug products with exposed skin, including on their wrists, which sheds particles and bacteria
  • Rust on the hood where sterile drugs are produced
  • Use of coffee filters to filter particulates
  • Toaster ovens used for sterilization

This revised draft guidance is intended to help compounding facilities identify insanitary conditions and implement corrective actions before they lead to harm. We also hope that issuing guidance on insanitary conditions will also serve as a resource to states, which are responsible for the day-to-day oversight of most compounders, in identifying and taking action to address insanitary conditions at the compounding facilities that they inspect. To protect the public health, it is critical that compounders correct any insanitary conditions at their facilities and that FDA and state regulatory agencies pursue appropriate action when they do not.

Federal law deems a drug to be adulterated if it is prepared, packed, or held under insanitary conditions whereby the drug may become contaminated with filth or rendered injurious to health. This provision of federal law applies to all drug producers, including compounding facilities. The revised draft guidance addresses drugs (including biological products) produced by pharmacies, federal facilities, and outsourcing facilities that compound or repackage drugs, or that mix, dilute, or repackage biological products. It reflects revisions to address many of the comments that we received on the initial draft. For example, it describes a policy specific to physicians (for example, allergists and dermatologists) producing drugs in their offices where the drugs are administered or dispensed to their own patients, as well as a policy that reflects unique considerations presented by manipulating radiopharmaceuticals.

I am heartened that since issuing the draft guidance on insanitary conditions in 2016, FDA has observed that many compounders have corrected insanitary conditions that prior FDA inspections of their facilities revealed. However, while we are encouraged by such voluntary compliance, the agency has also taken regulatory action, such as issuing warning letters or working with the Department of Justice on injunctions, when compounding facilities have neglected to take appropriate action to correct the violations.

Enhanced collaboration among the agency, the states, and compounders to address insanitary conditions represents a significant step forward in our shared goal of patient safety and to prevent another outbreak like what took place in 2012.

I’m going to switch gears to talk about our two final guidances that we issued today on compounding and repackaging of radiopharmaceuticals. We issued one guidance for state-licensed nuclear pharmacies, federal facilities, and other entities that hold a radioactive materials license for medical use and one for outsourcing facilities.

Sometimes, there is a need for a radiopharmaceutical compounded with just a “minor deviation” from the approved radiopharmaceutical, such as a change in radioactivity, volume, or step-by-step procedures. In other cases, a patient may need a radiopharmaceutical compounded using a bulk drug substance when, for example, the approved radiopharmaceutical is in shortage or the patient has an allergy to an ingredient in the approved product. In still other cases, an approved radiopharmaceutical may need to be repackaged—transferred from its original container into a different container without further manipulation of the product.

The guidances that we are issuing today address each of these three scenarios, seeking to strike the appropriate balance between preserving patient access to compounded and repackaged radiopharmaceuticals while reducing the risks that such unapproved drugs present to both patients and the integrity of FDA’s drug approval process. You will hear more about these final guidances later today.

FDA has also achieved several other significant goals described in the 2018 Compounding Policy Priorities Plan. For example, we issued a draft guidance regarding our evaluation of bulk drug substances nominated for use in compounding by outsourcing facilities, and two final guidances on compounded drugs that are essentially copies of commercially available or approved drug products, one applicable to compounding under section 503A, and one applicable to compounding under section 503B.

This is not an exhaustive list of our activities over the past year, and we will discuss these guidance documents and other activities later today and tomorrow. We also look forward to sharing additional policy developments with you as we seek to accomplish more goals described in the 2018 Compounding Policy Priorities Plan, as well as newer initiatives.

We are eager to engage with all of you on these important topics over the next two days, and you will hear more from my colleagues on our work on these fronts. We are looking forward to your feedback, and also to hearing about your ongoing work on the many facets of compounding regulation. I hope that this meeting proves as valuable to you as I know it will be to my colleagues.

Speaking of my colleagues, I just have to say that it is truly an honor and a privilege to work with such dedicated public servants as the staff here at FDA that work on compounding issues. The work is not easy, and the stakes – as we know – are high. But the passion and commitment each of them brings to promote and protect the public health in this space is inspiring to me and I wanted to thank them personally for their dedication to this important public health work.

Meaningful oversight of drug compounding has profound public health importance, and we thank you for continuing to partner with us to ensure that we put the well-being of patients, including their ability to access therapies of appropriate quality, first.

Thank you.

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