Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Silver Spring, MD 20993|
September 28, 2009
Hopewell Pharmacy and Compounding Center
Attention: Eugene Ragazzo, Owner
1 West Broad Street
Hopewell, NJ 08525-1901
Dear Mr. Ragazzo:
This Warning Letter concerns compounding activities performed by Hopewell Pharmacy and Compounding Center ("Hopewell") aka Drugs Are Us, Inc. In particular, this Warning Letter concerns Hopewell's compounding of Sodium Tetradecyl Sulfate (STS) Injection, 2%, 4% and 5%. The STS Injection, 2%, 4% and 5% strengths made by Hopewell are drugs within the meaning of section 201 (g) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 321 (g)]. As discussed below, these drugs and your production and distribution of these drugs violate the FDCA.
On June 4, 2008, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, located at West Broad Street, Hopewell, NJ. During the inspection, our investigator collected samples of Sodium Tetradecyl Sulfate (STS) finished product and active pharmaceutical ingredient. The Hopewell, NJ facility is licensed by the State of New Jersey Board of Pharmacy as a retail community pharmacy. The June 2008 inspection was a follow-up to assess whether commitments made during the October 2006 FDA inspection, regarding the discontinuation of the compounding of STS Injection, 1% and 3%, were upheld. This inspection found that your firm currently compounds STS Injection, 2%, 4% and 5% only. On June 4, 2008, FDA collected samples, consisting of 6 finished vials of STS Injection, 4%; 6 finished vials of STS Injection, 5%; STS aqueous stock solution, 27%; and the powder STS active pharmaceutical ingredient. These samples were subsequently analyzed by FDA and determined to be adulterated due to the presence of a contaminant, diethylene glycol monoethyl ether (DEGMEE), in the STS finished products and the STS aqueous stock solution.
Violations of the FDCA
Adulterated Drug Product
Analysis of the 6 finished vials of STS Injection, 4%; the 6 finished vials of STS Injection, 5%; and the STS aqueous stock solution, 27% indicates the presence of the DEGMEE contaminant in the aqueous stock solution and finished product samples.
Hopewell's STS Injection, 4% and 5% are adulterated under section 501(c) and (d)(1) of the FDCA [21 U.S.C. § 351(c) and (d)(1)]. These drug products are adulterated within the meaning of section 501(c) [21 U.S.C. sect; 351(c)] in that they are drugs that are not recognized in an official compendium and their strengths differ from, or their quality or purity fall below, that which they purport or are represented to possess. Further, DEGMEE has not been studied for use in injectable drugs and there are no approved drugs for injection that contain this material. Accordingly, there is no assurance of the safety of an injectable drug product containing DEGMEE. These drug products are also adulterated within the meaning of section 501(d)(1) of the FDCA [21 U.S.C. § 351(d)(1)] in that they are drugs and contain a substance, diethylene glycol monoethyl ether (DEGMEE), mixed therewith so as to reduce their quality or strength.
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist 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 assure 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 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.
Your written reply should be addressed to:
Stanley Shepperson, Pharm.D.
Regulatory Operations Officer
FDA/CDER/Office of Compliance
10903 New Hampshire Avenue, Bldg. 51, Room 5194
Silver Spring, MD 20993
Michael M. Levy, Jr.
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
This page was posted on January 31, 2010.