United States: Compounding Animal Drugs From Bulk Ingredients: Not Prohibited By Federal Food Drug And Cosmetic Act, Affirmed As Recently As 2011

Last Updated: July 11 2013
Article by Melissa Gilmore and Mary C. DeBartolo

The Federal Food Drug & Cosmetic Act (FD&CA) gives FDA broad, wide and far-reaching regulatory powers. Prohibiting the compounding of medicines from bulk ingredients, however, is not one of them. The position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients is simply incorrect.

A federal district court, the only court to review the issue, explicitly rejected the position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients:

The undisputed evidence ... shows that allowing the FDA to enjoin a pharmacist's traditional, state-authorized practice of bulk compounding of animal drugs could destabilize the pharmacy profession and leave many animal patients without necessary medication. Such a result would be especially troublesome because the FDA's longstanding policy has been to permit, and even promote, pharmacists' compounding from bulk ingredients. The FDA cannot simply upset the expectations it helped to create through decades of inaction without explanation, especially where it asserted expansion of authority impacts the federal-state balance and potentially subjects many individuals and companies to criminal liability.

United States v. Franck's Lab, Inc., et al. (816 F. Supp. 2d 1209 (M.D. Fl. 2011) (emphasis added)).

The FDA's Historical Regulation and Enforcement of Compounding with Bulk Substances Further Questions the Implied FD&CA Prohibition


For approximately the first 50 years after the enactment of the FD&CA in 1938, the FDA generally left regulation of compounding to the states.


United States v. 9/1 Kg. Containers (854 F.2d 173 (7th Cir. 1988)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished 9/1 Kg. Containers as being inapplicable to pharmacists.


United States v. Algon Chemical, Inc., (879 F.2d 1154 (3rd Cir. 1989)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished Algon Chemical, Inc. as being inapplicable to pharmacists.


The 1992 Compliance Policy Guide listed nine noninclusive activities that the FDA believed improperly crossed the line between "pharmacist" and "manufacturer." Compounding drugs from bulk substances was not among the nine prohibited practices.


Animal Medicinal Drug Use Clarification Act (AMDUCA) – The FDA regulations promulgated to implement AMDUCA. The regulations did not purport to regulate the practice of compounding and instead point to the FDA's nonbinding guidance documents regarding compounding. Further, the regulations distinguish between nonfood-producing animals and food-producing animals. With regard to nonfood-producing animals, the regulations state: "[b]ecause extralabel use of animal and human drugs in nonfood-producing animals ... does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened."


The 1996 Compliance Policy Guide listed 13 situations that would likely indicate compounding subject to regulatory action. Compounding from bulk drug substances for use in nonfood animals was expressly identified as a "compounding situation [which] would not ordinarily be considered a regulatory action." Compounding from bulk drugs for use in food animals, however, was one of the listed scenarios. The FDA noted in the Guide that there was "occasionally a need to utilize ... bulk drug substances for compounding into an appropriate dosage form." The FDA would thus condone compounding animal drugs from bulk where (1) a legitimate medical need was identified; (2) there was "a need for an appropriate dosage regimen" for the patient's species; and (3) there was "no marketed approved animal drug" that "may treat the condition diagnosed in the available dosage form." The FDA asserted in the Guide that "two Federal Appeals Court decisions, Algon and 9/1 kg. Containers, affirmed the FDA position that the FD&CA does not permit veterinarians to compound unapproved finished drug products from bulk drugs unless the finished drug is not a new animal drug. The principle established by the court applies equally to compounding by pharmacists." Notably, the FDA similarly asserted in the Guide that compounding a new animal drug from "an approved ... human or animal drug" would result in a violation of the FD&CA, but acknowledged that this would no longer be the case when the AMDUCA became effective.


The Food and Drug Modernization Act of 1997 (FDAMA) authorized pharmacists to compound drug products "using bulk drug substances" so long as the bulk drugs comply with the applicable USP monograph or if no monograph exists, the bulk drugs are components of drugs approved by the FDA.


In FDA v. Brown & Williamson (529 U.S. 120 (2000)), the Supreme Court found that in certain circumstances, a literal reading of a broadly drawn public health statute (specifically, the FD&CA) should be rejected when it encompasses conduct that exceeds the original congressional intent. The Court declared that "Congress could not have intended to delegate a decision of such economic and political significance to an agency in so cryptic a fashion" and the Court found that the FDA's claim to jurisdiction contravened the clear intent of Congress.


In Thompson v. Western States (535 U.S. 357 (2002)), the Supreme Court noted the importance of compounding and agreed with the government's position that because obtaining FDA approval for a new drug is a costly process, it would as a practical matter "eliminate the practice of compounding and thereby eliminate availability of compounded drugs for those patients who have no alternative treatment." Although the Supreme Court invalidated the advertising provisions of the FDAMA, the Court found that "it would not make sense to require compounded drugs created to meet the unique needs of individual patients to undergo the testing required for the new drug approval process." Furthermore, the Supreme Court expressly acknowledged the historical importance of traditional pharmacy compounding and openly questioned whether Congress could have intended to subject compounded drugs to the FD&CA's new drug approval process.


The 2002 Compliance Policy Guide addresses human drugs, but allows use of compounding from bulk for human drugs so long as the bulk ingredients are FDA-approved.


The 2003 Compliance Policy Guide addresses animal drugs. FDA did not publish the Guide in Federal Register or invite public comment. More than 70 members of Congress wrote separately to the FDA reiterating policy concerns of the 2003 Guide regarding compounding from bulk substances. While the 2002 Guide permits compounding of human drugs from bulk substances under certain circumstances, the practice was entirely prohibited for animals, except for nine listed exceptions, by the 2003 Guide. Further, while the 1996 Guide acknowledges the occasional utility of compounding from bulk, this was absent in the 2003 Guide. Note the disparate treatment of human and animal compounding: Under the 2002 and 2003 Guides, "a pharmacist who compounds medication from bulk for ingestion by a horse is ... subject to an FDA enforcement action, while the same pharmacist compounding medication from bulk for ingestion by the human rider of that horse is not."


FDA issued notice of revising the 2003 Guide but has never taken action to revise it. In 2005, 26 senators and 72 congressmen reiterated their displeasure over the agency's failure to revise the 2003 Guide and subject it to notice and comment procedures.


In Medical Center v. Gonzales (451 F.Supp.2d 854 (W.D. Tex. 2006)), the court, citing Algon and 9/1 Kg. Containers as additional support, held that compounded drugs are new animal drugs under the FD&CA, and unless the compounded drugs are exempt under the FD&CA's AMDUCA provisions, compounded drugs are subject to FD&CA's unsafe, adulteration and misbranding requirements. As with human drugs, the FD&CA contains no blanket "implicit exemption" for animal drugs produced by compounding.


A FDA Center for Veterinary Medicine (CVM) update from May 2007 regarding concerns about supplies of pergolide for horses noted CVM's efforts included trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for "animal use only." All pharmacy compounding must be done under a "valid veterinary prescription."


The court in Franck's Lab distinguished Algon and 9/1 Kg. Containers. The court noted that neither case mentioned pharmacists or the practice of pharmacy. Algon and 9/1 Kg. Containers also predated a number of important legal developments relating to both the FDA's regulation of compounding and the Chevron doctrine. The court held that in enacting the FD&CA in 1938, Congress did not intend to give the FDA per se authority to enjoin the longstanding, widespread, state-regulated practice of pharmacists' filling a veterinarian's prescription for a nonfood-producing animal by compounding from bulk substances.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.