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Q: What is compounding?
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Simply put, compounding is any manipulation of a drug beyond that stipulated on the drug label. Compounding should be implemented based on a licensed practitioner's prescription, to meet the medical needs of a specific patient.
Manipulation might include mixing, diluting, concentrating, flavoring, or changing a drug's dosage form to accommodate a specific patient's needs.
Examples of compounding would include:
- mixing two injectable drugs;
- creating an oral suspension from crushed tablets or an injectable solution;
- or adding flavoring to a commercially available drug.
AVMA has summarized its thoughts on compounding in a position statement.
Compounding for non-food animals may be necessary when no approved drug exists to treat a pet's diagnosed condition or when approved drugs need to be modified to sufficiently treat the patient (e.g. flavoring, diluting, or changing the form of medications from tablet to suspension).
In contrast, compounding that circumvents the drug approval process and mass markets products that have been produced with little or no verified quality control or manufacturing standards is clearly outside the bounds of traditional compounding. Such manufacturing of unapproved drugs might be termed "piracy" if the product mimics an FDA approved animal or human drug. Veterinarians might have seen businesses that offer their version of a popular approved brand name drug at lower prices than the approved product. Such a product is not custom compounded for a particular patient upon a veterinarian's prescription and is illegal.
Veterinarians can prescribe that pharmacists compound drugs for the veterinarian's "in-office use." The veterinarian may administer such drugs to patients, but re-dispensing of these products by the veterinarian to a client is generally prohibited.
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Q: Why is piracy bad?
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Piracy is bad for several reasons. First, it denies the patient treatment with an approved drug proven to be safe, effective, pure, potent, stable and made under FDA mandated "good manufacturing practices." Second, it exposes the patient to substances that have not been proven safe and effective and could be contaminated, sub- or super-potent, or unstable. Third, it exposes parties involved in piracy to unnecessary liability. Fourth, it undermines the incentive for research and development oriented animal pharmaceutical companies to market new animal drugs. Fifth, without a healthy animal pharmaceutical industry veterinarians will have fewer approved therapies. Sixth, it may involve preparation of drugs from bulk ingredients. These bulk ingredients often originate from developing countries that may lack a well-regulated chemical industry. These bulk ingredients may not be of the same quality as the bulk ingredients that the FDA requires a true drug manufacturer to use. Finally these bulk ingredients may come from countries where there are concerns about the real threat of bio-terrorism. And seventh, for these reasons it is illegal.
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Q: What is a bulk drug?
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Simply put, a bulk drug is a raw drug ingredient or chemical used to create a finished dosage form.
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Q: Does the FDA's Compliance Policy Guide (CPG) on compounding for animals disallow all compounding from bulk pharmaceutical ingredients?
A:
The fact is that compounding from bulk pharmaceutical ingredients for animals has been illegal for many years and continues to be illegal.
Although illegal, the FDA Center for Veterinary Medicine (CVM) acknowledges the medical need for compounding from bulk ingredients within certain areas of veterinary practice. Because of an absence of approved drugs for certain conditions, veterinarians require compounded drugs to treat conditions in a number of different species. The current CPG contains an appendix of bulk drugs that the FDA CVM has determined are needed by veterinarians and will normally not take action if those materials are compounded from bulk drugs. This is known as regulatory discretion.
What has concerned FDA is the issue of drug piracy, i.e. the mass marketing of drugs that mimic those that have been reviewed and approved by the FDA. The new FDA guide makes it clear that compounding from bulk drugs is an act that captures FDA's attention when the scope and nature of compounding raise the kinds of concerns normally associated with a drug manufacturer.
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Q: What is the AVMA's position on the CPG?
A:
AVMA's Council on Biologic and Therapeutic Agents (COBTA) is in communication with the FDA on the subject of the CPG. The Council is supportive of most of the aspects of the CPG, namely that piracy is clearly denounced. The Council is however seeking ways to more clearly specify that regulatory discretion should exist for veterinarians that prescribe and pharmacists that prepare medically necessary drugs compounded from bulk ingredients for specific pets when no such approved drugs exist.
At the present time, COBTA has not recommended to the AVMA Executive Board that FDA CVM be encouraged to withdraw the CPG because there are advantages and disadvantages to this strategy. The primary advantage is that revocation may speed up necessary changes. The primary disadvantage of withdrawal is loss of the foundation for enforcement actions against recognized drug piracy.
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Q: Is there anything else I should know?
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Yes. Federal extralabel drug use regulations specifically permit compounding from approved drugs when a veterinarian believes there is a need to alter the approved drug to adequately medicate a pet. So veterinarians that are contemplating flavoring, diluting or changing the dosage form of an approved drug are unaffected by the discussions pertaining to bulk drugs and the CPG.
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Q: Where can I read the new compounding CPG for myself?
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Access the FDA guide at www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html
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