Drug compounding is the term given to the process where doctors or pharmacists mix drugs to meet the specifications of the unique needs of a patient. Drug compounding is a common process and often times pharmacists like Hootan Melamed, Pharm D will compound drugs based on the prescription and advise of a doctor.
Pharmacists and doctors often mix injectable drugs, add flavouring to medicines and prepare pastes as well as suspensions out of tablets. All of these processes constitute drug compounding. Animal drug compounding is also very common where veterinarians request for or compound drugs themselves to treat animals. However, animal drug compounding is highly controlled.
Animal drug compounding legalities
Pharmacists are well aware that animal drug compounding is strictly controlled and it is only allowed in very specific cases. Pharmacists practising animal drug compounding must do so under strict FDA regulations as well as guidelines and know that the FDA does not consider the preparation of drugs by mixing raw and active ingredients as drug compounding.
According to FDA rules, compounding drugs should not be a way to circumvent the approved processes to make drugs that have been described by the FDA. Highly experienced pharmacists are thorough with the animal compounding guidelines listed in the FDA Regulations and Compliance Policy Guide 608.400 titled ‘Compounding of Drugs for Use in Animals’.
Regulations about animal drug compounding
The FDA has strict requirements for when animal compounding is allowed on pets and animals which produce food. Animal drug compounding is only allowed when:
- There is a valid relationship among the client, veterinarian and patient.
- The animal drug compounding is performed by a certified veterinarian or a pharmacist like Hootan Melamed, Pharm D on the request and guidance of a veterinarian and everything is within the scope of the professional as well as medical practice.
- The health of the animal is in serious danger and immense suffering and death will occur if the condition is not treated.
- Only drugs for animal and human use that have been approved by the FDA are being used in the animal drug compounding process. Bulk, raw and active ingredients cannot be used to compound drugs for animals.
- Labelled drugs are not available – for humans and animals, that can treat the condition that the animal is suffering from in any concentration or dosage form and there is no other way for the veterinarian to treat the condition.
Animal drug compounding for food producing animals is even more controlled than for pets. Animal drug compounding for animals that product food is prohibited in these cases:
- There is an animal drug that already exists that is FDA-approved, which can be used to treat the condition instead of drug compounding.
- The residue of the drug compounding may be a risk to public health in general.
Animal drug compounding is a very tricky process mired in legalities. So you need an experienced pharmacist like Hootan Melamed, Pharm D if you need animal drug compounding to treat your pet.
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