Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

by BakerHostetler

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance documents and six warning letters in the span of just a few months, has resulted in several important unanswered questions as to how the DQSA will impact various entities within the compounded pharmaceutical industry.

The U.S. Senate also has taken notice of this activity, and  on May 23, 2014, Senator Lamar Alexander (R-Tenn.), the senior Republican on the Senate Health Education, Labor and Pensions Committee and a member of the Senate Appropriations Committee, announced that, at his request, the Appropriations Committee had included language in its Report for the FY 2015 Agriculture Appropriations Bill (Report) directing the FDA to meet with stakeholders, such as doctors, patients and pharmacists, to discuss their implementation concerns. According to the Report, the Appropriations Committee “is concerned that the [FDA] is not meeting with any stakeholders before publicly releasing further guidance,” and has directed the FDA to meet with stakeholders “to ensure continued access to safe compounded drugs for which there is a clinical need.”

The Report noted that the FDA has made some efforts to clarify implementation of the DQSA. For example, on March 20 and 21, 2014, the FDA conducted an “Inter-Governmental Working Meeting on Pharmacy Compounding” with officials from state boards of pharmacy and national trade organizations to discuss implementation of the DQSA. The FDA also has released three guidance documents regarding implementation of the DQSA, the most recent of which allows stakeholder comment until June 2, 2014. But uncertainty persists within the industry as to how the DQSA will be enforced, particularly with respect to the classification of entities as traditional compounding pharmacies or “outsourcing facilities,” a type of entity created under the DQSA that voluntarily registers with the FDA in exchange for the opportunity to compound drugs without a prescription for office use and to ship compounded drugs across state lines without restriction.

The Appropriations Committee’s Report accompanied the FY 2015 Agriculture Appropriations Bill, which includes almost $4.5 billion in total funding for the FDA—an increase of $98 million over the total FY 2014 enacted level, and an increase of $12 million for drug safety activities specifically. Some of this funding likely will be used for enforcement activities related to the DQSA, which clarified and expanded the FDA’s regulatory authority over compounding pharmacies in the wake of a tragic fungal meningitis outbreak linked to contaminated vials produced by New England Compounding Center in 2012.

According to Senator Alexander’s statement, the purpose of the DQSA is to “end confusion and improve communication so we can help prevent another tragic meningitis outbreak.” “If the FDA isn’t sitting down with doctors, patients, and pharmacists and communicating how it is implementing the law,” Senator Alexander continued, “then I will stay on FDA until it does.”

These developments present an ideal opportunity for pharmacies, physicians, patients and other stakeholders to ensure that their voices are heard with regard to DQSA implementation.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© BakerHostetler | Attorney Advertising

Written by:


BakerHostetler on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.