United States: Animal Compounding Guidance (Draft) For Use Of Bulk Drug Substances Released By FDA Today

Last Updated: May 19 2015
Article by Brian J. Malkin

On May 18, 2015, FDA released new draft guidance on animal drug compounding from bulk drug substances. While FDA's current statutory framework and regulations do not permit compounding of animal drugs from bulk drug substances, FDA now recognizes that there are limited circumstances when an animal drug may be compounded from bulk substance. In particular, there are certain circumstances where there is no approved drug that can be used or modified through compounding to treat a particular animal with a particular condition. FDA's new guidance #230: Compounding Animal Drugs from Bulk Drug Substances further describes the circumstances where the Agency does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities, when drugs are compounded for animals from bulk drug substances. The Guidance does not apply to compounding animal drugs from approved new animal or human drugs, which may be conducted according to Section 512(a)(4) and (5) of the Federal Food, Drug and Cosmetic Act ("FD&C Act") (21 C.F.R. Part 530). These uses are considered "extralabel use", which has an exemption for such use under Section 502(f) of the FD&C Act e.g., use of a human chemotherapy drug to treat cancer compounded for use in dogs or cats, when the chemotherapy drug is approved for those specific animal species.

FDA's Director of the Center for Veterinary Medicine, Bernadette, Dunham, D.V.M., Ph.D., stated: "This draft guidance, once finalized, will help to ensure that animal drugs compounded from bulk drug substances are available for patient care without compromising the animal drug approval process or jeopardizing the safety of the food supply."

The Guidance proposes that such animal drug compounding may occur from bulk drug by or under the direct supervision of a licensed pharmacist in a state-licensed pharmacy when, among other things:

  • The drug is dispensed after receipt of valid prescription from a veterinarian for an individually-identified animal patient that comes directly from the prescribing veterinarian or the patients owner or caretaker to the compounding facility. Advance quantities may be compounded for an amount that does not exceed the amount that the state-licensed pharmacy compounded pursuant to patient-specific prescriptions based on such history for that drug product over any consecutive 14-day periods within the last 6 months.
  • The drug is not intended for food-producing animals with a prescription with the statement: "This patient is not a food-producing animal." Whether or not the food-producing animal, e.g., cattle, swine, chicken, turkey, sheep, goats, or non-ornamental fish, is actually intended to be introduced into food chain is not relevant for this consideration.
  • If the drug contains a bulk drug substance from a human or animal drug approved for marketing by FDA, then any change in the drug must be identified by the veterinarian prescribing the compounded drug along with the documented reason why the change would produce a clinical difference for that individually-identified animal patient and cannot be compounded from the human or animal drug, e.g., the approved animal or human drug contains a dose so large that it cannot be divided or diluted to the dose required by the specific animal, i.e., extralabel use is not possible.
  • The pharmacy must receive along with the prescription documentation and a statement: "There are no FDA-approved animal or human drugs that can be used as labeled or in an extralabel manner under section 512(a)(4) or (5) and 21 CFR part 530 to appropriately treat the disease, symptom, or condition for which this drug is being prescribed."
  • The bulk drug substances used must be manufactured by an establishment registered under Section 510 of the FD&C Act along with a valid certificate of analysis.
  • The drug is compounded according to Chapters <795> and <797> of the United States Pharmacopeia and National Formulary ("USP-NF"), including sterile drug compounding.
  • The drug is not sold or transferred by an entity other than the entity that compounded the drug.
  • Within 15 days of becoming aware of any product defect or serious adverse event associated with the drug compounded from bulk drug substances, the pharmacy reports it to FDA on Form FDA 1932a.
  • The label of the compounded drug indicates the species of the intended animal patient, the name of the animal patient, and the name of the owner or caretaker of the animal patient.

For animal drugs compounded by a licensed veterinarian, the conditions for compounding using bulk drug substances are similar with the following modifications:

  •  The drug is compounded and dispensed by a veterinarian to treat an individually-identified animal patient under his care.
  • There are no FDA-approved animal or human drugs that can be used as labeled or in an extralabel manner under section 512(a)(4) or (5) and 21 CFR Part 530 to appropriately treat the disease, symptom, or condition for which this drug is being prescribed.
  • These provisions do not appear to include similar provisions for advance compounding as with the pharmacy.

For animal drugs compounded by an outsourcing facility, the provisions are similar with the following modifications:

The drugs are compounded only from bulk substances appearing in the appendix list to be developed in conjunction with this Guidance.

  • The drug is compounded by or under the supervision of a licensed pharmacist.
  • The drug is compounded in accordance with cGMP requirements.
  • These provisions also do not appear to include similar provisions for advance compounding as with the pharmacy.
  • All drugs compounded by animals by an outsourcing facility are included in the report required by 503B of the FD&C Act to be submitted to FDA each June and December identifying the drugs made by the outsourcing facility during the previous 6-month period, along with the active ingredients and their source(s), NDC number of the source ingredient(s), strength of the active ingredient(s) per unit, the dosage form and route of administration, package description, number of individual units produced, and the NDC number of the final product, if assigned, along with which reported drugs were intended for animal use.
  • The veterinarian's prescription or order states that the drug is intended to treat the species and condition(s) for which the substance is listed in the appendix developed in conjunction with the Guidance.
  • Certain product labeling, including language such as "Not for resale.", "Compounded by [name of outsourcing facility]" and "Adverse events associated with this compounded drug should be reported to FDA on Form FDA 1932a."

Along with the Guidance, FDA is developing a list of bulk drug substances that facilities registered as outsourcing facilities under section 503B of the FD&C Act can use to compound for an individual animal patient or veterinarian office use under specified conditions. FDA is soliciting in a Federal Register notice to publish tomorrow public input on which bulk drug substances should be placed on the list. The draft Guidance and nominations for the list of bulk drug substances will have 90 days for comment. Following the initial list, FDA intends to review the nominated bulk drug substances on a rolling basis to periodically update the list. Finally, FDA also withdrew Compliance Policy Guide Section 608.400 Compounding of Drugs for Use in Animals, because the Agency said it was no longer consistent with its current thinking on these issues.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions