Inspections, Compliance, Enforcement, and Criminal Investigations
Med Prep Consulting, Inc 7/9/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Parsippany, New Jersey 07054|
July 9, 2010
RETURN RECEIPT REQUESTED
Gerald R. Tighe, President
Med Prep Consulting, Inc.
1540 West Park Avenue, Suite 5
Tinton Falls, New Jersey 07712
Dear Mr. Tighe:
During the period of December 1-8, 2009, U.S. Food and Drug Administration (FDA) investigators conducted an inspection at your facility known as Med Prep Consulting Inc., located at 1540 West Park Avenue, Suite 5, Tinton Falls, NJ 07712. The inspection revealed that your firm repackages sterile drug products. According to a document collected during the recent inspection, it appears that your firm enters into a "Repackaging Services Agreement" with its clients. This agreement demonstrates your firm's practice of repackaging sterile drug products for other entities, including hospital pharmacies, without a prescription from a licensed practitioner. FDA does not consider your practice of repackaging and distributing drugs without patient-specific prescriptions to constitute the regular course of a pharmacy's business of dispensing and selling drugs at retail.
FDA regards mixing, packaging, and other manipulations of approved drugs by licensed pharmacists, consistent with the approved labeling of the product and pursuant to prescriptions for identified patients, to be within the practice of pharmacy. Processing and repacking (including repackaging) of approved drugs for resale by other pharmacies or entities, however, exceeds the traditional practice of pharmacy. Consequently, your firm is Subject to the current Good Manufacturing Practice (cGMP) requirements for drugs as described in section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351 (a)(2)(B)] and 21 CFR parts 210 and 211. The cGMP regulations applicable to repackagers help prevent drug product mix-ups and contamination, among other potential public health hazards. In addition, these regulations require assurances about the stability of repackaged drug products from the time the drug is repackaged until it is actually dispensed to a patient.
FDA is particularly concerned about the manipulation of sterile drug products when a sterile container is opened or otherwise entered to conduct manipulations. The moment a sterile container is opened and manipulated, a quality standard (sterility) is destroyed and previous studies supporting the standard are compromised and are no longer valid. We are especially concerned with the potential microbial contamination associated with splitting single-use, preservative-free, vials into multiple doses. Drugs that are not repackaged according to cGMP requirements are adulterated under section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)].
Because of your repackaging practices, section 510 of the FDCA [21 U.S.C. § 360] requires you to register with FDA and submit a listing of all of the drugs that you are repackaging. Until these requirements are met, drugs that are repackaged by your firm are also misbranded under section 502(o) of the FDCA [21 U.S.C. § 352(o)].
Section 301(a) of the FDCA [21 U.S.C. § 331 (a)] prohibits the introduction or delivery for introduction into interstate commerce of any adulterated or misbranded drug. In addition, section 301(k) of the FDCA [21 U.S.C. § 331(k)] prohibits any act with respect to a drug if the act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated or misbranded.
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. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
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 the cited violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Address your reply to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd, 3rd floor, Parsippany, NJ 07054, Attention: Sarah A. Della Fave, Compliance Officer.
Diana Amador Toro
New Jersey District
U.S. Food and Drug Administration