Plainsboro Pharmacy - 493319 - 08/01/2016
- Plainsboro Pharmacy
- Issuing Office:
- New Jersey District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Jersey District Office|
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
August 1, 2016
VIA UNITED PARCEL SERVICE
Yousry Macksoud, Pharmacist-in-Charge and Owner
9 Schalks Crossing Road
Plainsboro, NJ 08536
Dear Mr. Macksoud:
On July 30, 2014, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Plainsboro Pharmacy, located at 9 Schalks Crossing Road, Plainsboro, New Jersey. This inspection was conducted after receipt of an adverse event report associated with sustained release liothyronine (T3) capsules prepared by your firm.
Based on this inspection, it appears that you are compounding drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. Violations of the FDCA
Adulterated Drug Products
As noted, FDA received a MedWatch report dated July 17, 2014, regarding an adverse event reportedly experienced by a patient who received sustained release liothyronine (T3) capsules prepared by your firm. The product was labeled liothyronine 2.5 meg per capsule. FDA analysis of a sample of the product received from the patient found that it contained approximately 2.3 mg of liothyronine per capsule, which far exceeds the label claim. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. The strength of your sustained release liothyronine (T3) capsules differed from and greatly exceeded the labeled amount of liothyronine the product was purported to possess, causing it to be adulterated under section 501(c) of the FDCA.
It is a prohibited act under section 301(k) ofthe FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce of the components used to make the drug and results in the drug being adulterated.
Misbranded Drug Products
Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. As noted, FDA analysis showed that your sustained release liothyronine (T3) capsules contained in excess of the labeled concentration of liothyronine. Because the labeling of this drug product was false, it was misbranded under section 502(a) of the FDCA.
It is a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce of the components used to make the drug and results in the drug being misbranded.
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. 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 ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 the corrective actions within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please address your reply to: Acting Compliance Branch Director, New Jersey District Office, U.S. Food and Drug Administration, 10 Waterview Blvd., Floor 3, Parsippany, NJ 07054.
If you have questions regarding the contents of this letter, please contact Ms. Durso at 973-331-4911.
Craig W. Swanson
Acting District Director
New Jersey District
Anthony Rubinaccio, Executive Director
New Jersey State Board of Pharmacy
PO Box 45013
Newark, NJ 07101