Public Health Service Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
August 14, 2014
Jacqueline S. Bernard, President and Owner
Wickliffe Pharmaceutical, Inc.
4340 Georgetown Road
Lexington, KY 40511
Dear Ms. Bernard:
From April 29 to May 22, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your compounding pharmacy located at 4340 Georgetown Road, Lexington, KY. As described below, FDA’s investigation revealed that animal drug products compounded by your firm are adulterated and misbranded under the Federal Food, Drug and Cosmetic Act (FD&C Act). You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov. An FDA Form 483 was issued to you on May 22, 2014, outlining some of FDA’s concerns.
FDA initiated an investigation of your pharmacy following the death of two horses in Kentucky after an application of an oral paste containing toltrazuril and pyrimethamine that was compounded by your pharmacy. While the investigation was ongoing, FDA received a report that eight horses in Florida had suffered adverse reactions after they were treated with a suspension drug product compounded by your pharmacy that also contained toltrazuril and pyrimethamine. Two of those horses died. Samples of the paste and the suspension product were collected by FDA for testing.
B. Violations of the FD&C Act
Our investigation revealed that on March 25, 2014, you compounded a paste with lot number 25-03-2014@25 and prescription number 311791. The label for the paste stated that it contained toltrazuril 227mg/ml and pyrimethamine 340mg/ml. FDA analyzed two samples of the paste to determine the concentration of each drug.
The results for the first sample showed:
Toltrazuril 182 mg/ml, which is 80 percent of the declared concentration, and
Pyrimethamine 277 mg/ml, which is 82 percent of the declared concentration.
The results for the second sample showed:
Toltrazuril 184 mg/ml, which is 81 percent of the declared concentration, and
Pyrimethamine 283 mg/ml, which is 83 percent of the declared concentration.
The investigation also revealed that on April 2, 2014, you compounded a suspension drug product with lot number 28-03-2014@44 and prescription number 294545. The label for this product stated it contained the drug toltrazuril 416 mg/ml and the drug pyrimethamine 17 mg/ml. However, FDA analyzed a sample of the product to determine the concentration of each drug and found that it contained:
Toltrazuril 15.5 mg/ml, which is 3.74% of the declared concentration; and
Pyrimethamine 405 mg/ml, which is 2380% of the declared concentration.
Deviations of the actual concentrations of the drugs from their labeled concentrations cause the suspension product and the paste to be adulterated under Section 501(c) of the FD&C Act [21 U.S.C § 351(c)] because their strength differs from that which they purport or are represented to possess. The introduction or delivery for introduction into interstate commerce of these products therefore violates Sections 301(a) of the Act [21 U.S.C. § 331(a)].
Additionally, the suspension product and the paste compounded by your firm were misbranded within the meaning of Section 502(a) of the FD&C Act [21 U.S.C. § 352(a)] because their labeling was false and misleading. As discussed above, product samples indicate that the suspension product and paste were sub-potent and/or super-potent in comparison with their labeled potency, which makes their labeling false. The introduction or delivery for introduction into interstate commerce of these products therefore violates Sections 301(a) of the Act [21 U.S.C. § 331(a)].
Please note that the violations cited in this letter are not intended to be an all-inclusive list of violations at your facility. As a pharmacy engaged in distributing drugs in interstate commerce you are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at (513)679-2700, ext. 2163, or firstname.lastname@example.org.