Inspections, Compliance, Enforcement, and Criminal Investigations
Spectrum Chemicals & Laboratory Products, Inc 28-Nov-05
Department of Health and Human Services
Public Health Service
Telephone (973) 526-6006
November 28, 2005
CERTIFIED MAIL -
RETURN RECEIPT RE4UESTED
Ms. Elizabeth Ferguson-Brown
Chief Executive Officer
Spectrum Chemicals and Laboratory Products, Inc
7400 North Oracle Road
Tuscon, AZ 85704
Dear Ms. Ferguson-Brown:
On July 12-20, 2005, an investigator from the U.S. Food and Drug Administration (FDA) inspected Spectrum Chemicals and Laboratory Products, Inc., located at 755 Jersey Avenue, New Brunswick, New Jersey. This inspection revealed that your firm receives active pharmaceutical ingredients (APIs) from manufacturers and distributors. Some of these APIs are then repackaged and relabeled for distribution to pharmacies for compounding.
Your firm received a warning letter in June of 2004, based on its distribution of domperidone API. Domperidone is not a component of an FDA-approved drug and the agency does not tolerate its distribution for human drug compounding. As FDA noted in the June 2004 warning letter, Section 127 of the 1997 FDA Modernization Act amended the Federal Food, Drug, and Cosmetic Act (the Act) by adding section 503A, which specified certain conditions under which compounded human drugs could be exempt from particular requirements of the Act. In April 2002, however, the United States Supreme Court struck down the commercial speech restrictions in section 503A of the Act as unconstitutional . Accordingly, all of section 503A is now invalid.
As a result, the agency utilizes its longstanding policy to exercise its enforcement discretion regarding certain types of pharmacy compounding. This policy is articulated in Compliance Policy Guide, section 460.200 ("the CPG"), issued on June 7, 2002. The CPG contains factors that the agency considers in deciding whether to exercise its enforcement discretion. One factor is whether a firm is compounding finished drugs from bulk active ingredients that are not components of FDA-approved drugs without an FDA sanctioned investigational new drug application, as required by 21 U.S.C. § 355(i) and 21 CFR Part 312.
The factors listed in the CPG are not intended to be exhaustive, and other factors may be appropriate for consideration, including whether a compounded drug may have a potential adverse effect on the public health.
FDA's most recent inspection revealed that your firm is repacking and distributing the API polidocanol for use in pharmacy compounding. FDA is very concerned about the public health risks associated with compounded polidocanol. Known adverse events include deep venous thromboses, necrosis, and ulceration at the treated site. Additionally, reversible cardiac arrest after polidocanol sclerotherapy has been reported.
The polidocanol distributed by your firm to pharmacies for compounding is misbranded within the meaning of section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)). It does not qualify for the section 502(f)(1) exemption set forth in 21 CFR § 201.115, because it is offered to compound drug products that are new drugs under section 201(p) of the Act (21 U.S.C § 321(p)) and that lack approved applications under section 505 of the Act (21 U.S.C. § 355).
Polidocanol is not an active ingredient contained in any FDA-approved drug product. FDA does not sanction its use in pharmacy compounding and will not exercise its enforcement discretion for compounded products containing polidocanol. FDA also will not exercise its enforcement discretion with regard to the distribution of polidocanol API.
Furthermore, the list of APIs produced during the inspection indicates that your firm distributes adenosine-5-monophosphate to pharmacies for compounding. Drugs containing adenosine-5-monophosphate were removed from the market in 1973 for safety reasons. For the reasons explained above, adenosine-5-monophosphate API distributed for pharmacy compounding is misbranded under the Act. FDA will not exercise its enforcement discretion for compounded products containing adenosine-5-monophosphate, and we will not exercise enforcement discretion with regard to the distribution of the API.
You were clearly warned in June of 2004 that you may not distribute APIs for compounding that are not components of approved drugs. The fact that you have continued this practice is extremely troubling. It is your responsibility to ensure that your frm's products are in compliance with Federal laws and regulations. Failure to correct the violations cited previously and in this letter may lead to enforcement actions including, but not limited to, seizure of your products or injunction. Federal agencies are routinely advised of warning letters issued so that they may take this information into account when considering the award of government contracts.
Please notify this office in writing within 15 working days of receipt of this letter of the steps that you have taken to correct these violations, including an explanation of the steps taken to prevent the recurrence of similar violations. If the violations have not been corrected, state the reason for the delay and the date by which correction will occur. You should address your reply to the U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054, Attn: Robert J. Maffei, Compliance Officer.
Douglas I. Ellsworth
New Jersey District