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FDA Guidance for Industry Document #256 |
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Compounding Animal Drugs from Bulk Drug Substances - Part 4
This version of the guidance replaces the version made available April 2022. This revision provides the approved information collection OMB Control No. 0910-0904
The release of this FDA GUIDANCE has stimulated a lot of discussion. The FDA will receive comments on it as described below. To strengthen our voice, please join APC and participate in the educational programming offered on this topic and read and participate in the discussions on the IJPC Compounders' Network List.
Over the next several weeks, this Newsletter will present a section per week in an easy-to-read- format that should only take a few minutes to become acquainted with the document. The highlighted section in the TOC below will be covered in the respective Newsletters.
This guidance represents the Food and Drug Administration's (FDA or Agency) current thinking on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
A complete copy of the Guidance with footnotes and comments may be downloaded at:
guidance-documents, or www.regulations.gov.
Compounding Animal Drugs from Bulk Drug Substances Guidance for Industry
Table of Contents
- INTRODUCTION (Covered previously)
- BACKGROUND (Covered previously)
- Legal Marketing Pathways for Animal Drugs
- Animal Drugs Compounded from Bulk Drug Substances
- POLICY (Section A of the "POLICY"section was covered in last week's newsletter. Sections B and C will be covered in this newsletter.)
- Compounding for Nonfood-Producing Animals: Patient-Specific Prescriptions (covered in last week's Newsletter)
- Compounding for Nonfood-Producing Animals: Without Patient-Specific Prescriptions (“Office Stock�)
- Compounding for Food-Producing Animals: Drugs for Use as Antidotes for Food-Producing Animals or Sedatives and Anesthetics for Free-Ranging Wildlife Species
- PAPERWORK REDUCTION ACT OF 1995
APPENDIX – Request for Nominations to:
- The List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals; or
- The List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species
Examples of food-producing animals include cattle, swine, chickens, turkeys, sheep, goats, fish (excluding ornamental and aquarium fish) and other aquatic animal species, gamebirds and wildlife raised or harvested for food, and honeybees.
For purposes of this guidance, a drug is "marketed" if the drug manufacturer is making and offering the drug for sale. For animal drugs that are temporarily in shortage, FDA will apply its process for mitigating shortages. Actions may include working with drug manufacturers and others in the animal health industry, speeding up the animal drug review and approval process, encouraging sponsors of alternate products to increase production, or refraining from taking action against imports of foreign-approved versions of the drug product. Available at:
https://www.fda.gov/animal-veterinary/product-safety-information/animal-drug-shortage-information
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Section B. Compounding for Nonfood-Producing Animals: Without Patient-Specific Prescriptions ("Office Stock")
At this time, FDA generally does not intend to take enforcement action against the compounding of animal drugs from bulk drug substances as office stock for nonfood-producing animals for violations of the requirements for animal drug approval, adequate directions for use, and CGMP when all of the circumstances below are present:
- The drug is compounded by or under the direct supervision of a veterinarian, or a pharmacist in a State-licensed pharmacy or a Federal facility;
- The drug is intended for use in a nonfood-producing species and is compounded from a bulk drug substance listed on FDA's "List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals" described in the Appendix to this guidance;
- The drug is compounded in full compliance with State laws and regulations governing drugs, pharmacy, and veterinary medicine. All bulk drug substances, inactive ingredients, and finished drug products used in compounding meet the standards set in any applicable USP-NF monograph and comply with other FD&C Act requirements for drug components;
- The veterinarian who stocks the drug dispenses or transfers it only to the owner or caretaker of the animal patient or to another veterinarian in the same practice.
The enforcement discretion policy described in this guidance does not apply to compounded drugs that are transferred to a third party such as a distributor, retailer, or veterinarian at another physical location;
Upon becoming aware of any adverse event or product defect associated with an animal drug compounded from a bulk drug substance, the pharmacist or veterinarian that compounded the drug reports the event on Form FDA 1932a, which is available online, within 15 business days; and
- The labeling of the compounded drug includes all of the following: name of drug;
- strength of drug;
- the species of the patient(s) and indication(s) for which the drug will be used;
- the name, address, and contact information for the compounding pharmacy or compounding veterinarian;
- the name, address, and contact information for the veterinarian ordering the office stock;
- a beyond-use date;
- the statement, "Report suspected adverse reactions to the [pharmacist or veterinarian who compounded the drug] and to FDA using online Form FDA 1932a";
- the statement, "This is a compounded drug. Not an FDA approved or indexed drug.";
- the statement, "Not for use in food-producing animals"; and
- the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."
21 CFR 201.105(b)(1)
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Section C. Compounding for Food-Producing Animals: Drugs for Use as Antidotes for Food-Producing Animals or Sedatives and Anesthetics for Free-Ranging Wildlife Species
At this time, FDA generally does not intend to take enforcement action against the compounding of drugs from bulk drug substances intended for use as antidotes for treating toxicoses in food-producing animals or for use as sedatives or anesthetics in free-ranging wildlife species for violations of the requirements for animal drug approval, adequate directions for use, and CGMP when all of the circumstances below are present:
- The drug is compounded by or under the direct supervision of a veterinarian, or a pharmacist in a State-licensed pharmacy or a Federal facility;
- The drug is compounded from a bulk drug substance on the "List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species;
- The prescribing veterinarian has a valid veterinarian-client-patient relationship and establishes and documents a scientifically based withdrawal time that ensures residues of the: (1) antidote, or (2) sedative or anesthetic are not present in the animal at the time of slaughter or harvest or the veterinarian ensures the animal does not enter the food supply
- Section 402(a) of the FD&C Act (21 U.S.C. § 342(a)); 21 CFR 530.20(b)(2) ;
- The prescribing veterinarian ensures that the animal does not enter the food supply too soon or at all. This can be done by confining the treated animal for the needed withdrawal time or identifying the animal(s) that has been treated. For example, for free-ranging wildlife the animal could be identified with a tag containing language such as "DO NOT CONSUME if harvested before [enter date after completed withdrawal period]; Call [enter phone number of veterinarian or animal health professional].";
- Upon becoming aware of any adverse event or product defect associated with a drug compounded from a bulk drug substance, the pharmacist or veterinarian who compounded the drug reports the event on Form FDA 1932a, which is available online, within 15 business days; and
- The labeling of the antidote, sedative, or anesthetic includes all of the following:
- name of drug;
- strength of drug;
- the species of the patient(s) and indications for which the drug will be used;
- the name, address and contact information for the compounding pharmacy or compounding veterinarian;
- the name, address, and contact information for the compounding pharmacy or compounding veterinarian;
- the name, address, and contact information for the veterinarian ordering the antidote, or the wildlife health professional ordering the sedative or anesthetic;
- a beyond use date;
- prescribing veterinarian-determined withdrawal time;
- the statement, "Report suspected adverse reactions to the [pharmacist or veterinarian who compounded the drug] and to FDA using online Form FDA 1932a";
- the statement, "This is a compounded drug. Not an FDA approved or indexed drug."; and
- the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."
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To be Continued next week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Did You Know (On Speech) ...
... The following?
"Little said is soonest mended." (Anon)
"A man's character is revealed by his speech." (Greek Proverb)
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Thoughts for the Week (On Time)
"Nothing treads so silent as the foot of time." (Anon)
"All the treasures of earth cannot bring back one lost moment." (French Proverb)
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From Out of the Past
Substitutes
Like unseen barter
Often make one
Sad
But smarter.
Burma-Shave
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