A person I know tested positive for a high bute level after a horse race. The acceptable level is 5 micrograms. His horse tested positive at 18 micrograms. The horse was disqualified from the finals of a futurity. Should the veterinarians be accountable for selling an illegal and un-validated bute powder? This is what he submitted to the racing commission.
Friday I administered 2 1/2 full scoops of Weatherford Compounding Pharmacy Phenylbutazone Powder. “Each scoop contains phenylbutazone 1 Gram- molasses flavor”. The veterinarian from …………………………………….. Said to use 2 ½ scoops of the Weatherford Compounding Pharmacy Phenylbutazone Powder. The Weatherford Compounded bute was purchased from ……………. in South Jordan.
There are no directions on the jar of Compounded bute powder, except “each scoop contains phenylbutazone 1 gram”. No directions: Not a light fluffy scoop, Not a level packed scoop, Not a level fluffy scoop, Not a heaping full scoop!
Each scoop is supposed to deliver 1 gram of phenylbutazone with a gross weight of 1.20 grams per scoop including molasses flavoring and other inactive ingredients.
The 5cc scoop is not validated to deliver 1.20 grams of total product with 1 gram of phenylbutazone.
1 gram of phenylbutazone/1.20 total weight=83.333% phenylbutazone per scoop.
Each 5cc scoop contains 2.37 grams of total weight delivering 1.975 grams of phenylbutazone.
With two and half 5cc scoops (5.93 grams)the total minimum amount delivered to the horse was 4.937 grams of phenylbutazone.
With two and half 5cc heaping scoops the total weight delivered to the horse was 9.85 grams, with 8.20 grams of phenylbutazone.
The 5cc scoop is flawed and not validated or calibrated to the formula! The blood concentration (T-Max) after administration of a fasted horse for phenylbutazone on the average is 6.5 hours.
The blood concentration (T-Max) after administration of an eating horse for phenylbutazone on the average is 9 hours.
There are many forms of FDA approved phenylbutazone products on the market: Paste, injectable, tablets, and powder.
A letter stated directly to veterinarians from the FDA and through AAEP. “Phenylbutazone can only be legally compounded by using an FDA-approved phenylbutazone product as the starting material. Phenylbutazone should not be compounded from bulk (raw materials). An animal drug that is compounded from bulk drug ingredients is not FDA approved, and therefore, the safety and effectiveness of the compounded drug, as well as the adequacy of the manufacturing process, have not been evaluated”. In 2005, the American Association of Equine Practitioners produced compounding guidelines to veterinarians as follows: “The use of bulk drugs in preparation of compounded medications is…..illegal because it results in the production of an unapproved new animal drug.” “The prescribing veterinarian should remember that compounded drugs have not been evaluated by the FDA approval process for safety, efficacy, stability, potency and consistency.” Be aware that compounding drugs to mimic licensed, FDA-approved drugs is illegal.” Assuming there is an FDA-approved product that is in the appropriate dosage form (Powder, tablet, paste, injectable in 1 gram potency) that can be used for the specific patient indication, veterinarians cannot use compounded “Look-alike” as substitutes. The decision to use the products, in lieu of the FDA-approved product, is illegal and potentially jeopardizes the patient and the veterinarian’s liability insurance.
Dr. James Morehead, President of AAEP states “The prescribing veterinarian assumes responsibility, liability when using these products”. In 2007, Dr. James Morehead warns veterinarians again about the dangers and unethical practices of veterinarians using illegal compounded drugs. (Legal) “Compounded products must be made from an FDA-approved commercially available animal or human drug”. “Veterinarians cannot use compounded drugs to merely save money over other FDA-approved available products that a compounding pharmacy may claim are similar”.
Weatherford Compounding Pharmacy Phenylbutazone is illegal.
It is compounded from bulk raw materials-illegal.
It has no FDA ANADA# on the label.
It has no directions on the label.
The blue 5cc scoop is not validated to deliver the 1.20 grams of product.
The phenylbutazone has not under gone an FDA bio-equivalency study with FDA approved phenylbutazone products.
The inactive ingredient molasses may be an accelerant in absorption into the blood.
Compounded phenylbutazone is not for resale at a profit-illegal.
Weatherford Pounding Pharmacy phenylbutazone powder 83.3% infringes on patent number 8,524,759 B2.
Veterinarians selling compounded phenylbutazone powder is illegal and unethical. Veterinarians at ………………………..are members of the AAEP(American Association of Equine Practitioners).
AAEP has been warning veterinarians of illegal compounding for over 14 years.
I purchased Weatherford Compounding phenylbutazone in good faith from ……………..in good faith that it was ethical and legal.
quoted from here Also read additional comments and complete discussion posted on the forum.
Friday I administered 2 1/2 full scoops of Weatherford Compounding Pharmacy Phenylbutazone Powder. “Each scoop contains phenylbutazone 1 Gram- molasses flavor”. The veterinarian from …………………………………….. Said to use 2 ½ scoops of the Weatherford Compounding Pharmacy Phenylbutazone Powder. The Weatherford Compounded bute was purchased from ……………. in South Jordan.
There are no directions on the jar of Compounded bute powder, except “each scoop contains phenylbutazone 1 gram”. No directions: Not a light fluffy scoop, Not a level packed scoop, Not a level fluffy scoop, Not a heaping full scoop!
Each scoop is supposed to deliver 1 gram of phenylbutazone with a gross weight of 1.20 grams per scoop including molasses flavoring and other inactive ingredients.
The 5cc scoop is not validated to deliver 1.20 grams of total product with 1 gram of phenylbutazone.
1 gram of phenylbutazone/1.20 total weight=83.333% phenylbutazone per scoop.
Each 5cc scoop contains 2.37 grams of total weight delivering 1.975 grams of phenylbutazone.
With two and half 5cc scoops (5.93 grams)the total minimum amount delivered to the horse was 4.937 grams of phenylbutazone.
With two and half 5cc heaping scoops the total weight delivered to the horse was 9.85 grams, with 8.20 grams of phenylbutazone.
The 5cc scoop is flawed and not validated or calibrated to the formula! The blood concentration (T-Max) after administration of a fasted horse for phenylbutazone on the average is 6.5 hours.
The blood concentration (T-Max) after administration of an eating horse for phenylbutazone on the average is 9 hours.
There are many forms of FDA approved phenylbutazone products on the market: Paste, injectable, tablets, and powder.
A letter stated directly to veterinarians from the FDA and through AAEP. “Phenylbutazone can only be legally compounded by using an FDA-approved phenylbutazone product as the starting material. Phenylbutazone should not be compounded from bulk (raw materials). An animal drug that is compounded from bulk drug ingredients is not FDA approved, and therefore, the safety and effectiveness of the compounded drug, as well as the adequacy of the manufacturing process, have not been evaluated”. In 2005, the American Association of Equine Practitioners produced compounding guidelines to veterinarians as follows: “The use of bulk drugs in preparation of compounded medications is…..illegal because it results in the production of an unapproved new animal drug.” “The prescribing veterinarian should remember that compounded drugs have not been evaluated by the FDA approval process for safety, efficacy, stability, potency and consistency.” Be aware that compounding drugs to mimic licensed, FDA-approved drugs is illegal.” Assuming there is an FDA-approved product that is in the appropriate dosage form (Powder, tablet, paste, injectable in 1 gram potency) that can be used for the specific patient indication, veterinarians cannot use compounded “Look-alike” as substitutes. The decision to use the products, in lieu of the FDA-approved product, is illegal and potentially jeopardizes the patient and the veterinarian’s liability insurance.
Dr. James Morehead, President of AAEP states “The prescribing veterinarian assumes responsibility, liability when using these products”. In 2007, Dr. James Morehead warns veterinarians again about the dangers and unethical practices of veterinarians using illegal compounded drugs. (Legal) “Compounded products must be made from an FDA-approved commercially available animal or human drug”. “Veterinarians cannot use compounded drugs to merely save money over other FDA-approved available products that a compounding pharmacy may claim are similar”.
Weatherford Compounding Pharmacy Phenylbutazone is illegal.
It is compounded from bulk raw materials-illegal.
It has no FDA ANADA# on the label.
It has no directions on the label.
The blue 5cc scoop is not validated to deliver the 1.20 grams of product.
The phenylbutazone has not under gone an FDA bio-equivalency study with FDA approved phenylbutazone products.
The inactive ingredient molasses may be an accelerant in absorption into the blood.
Compounded phenylbutazone is not for resale at a profit-illegal.
Weatherford Pounding Pharmacy phenylbutazone powder 83.3% infringes on patent number 8,524,759 B2.
Veterinarians selling compounded phenylbutazone powder is illegal and unethical. Veterinarians at ………………………..are members of the AAEP(American Association of Equine Practitioners).
AAEP has been warning veterinarians of illegal compounding for over 14 years.
I purchased Weatherford Compounding phenylbutazone in good faith from ……………..in good faith that it was ethical and legal.
quoted from here Also read additional comments and complete discussion posted on the forum.
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