Daphne (Pai) Lau
c/o InterChem Trading Corp.
120 Route 17 North
Paramus, New Jersey 07652

          Re:  Violation of debarment;
                  58 Fed. Reg. 59048 (Nov. 5, 1993)

Dear Ms. Lau:

It has come to the attention of the United States Food and Drug Administration (FDA), that you are employed by InterChem Trading Corp. (InterChem). For the reasons set forth in this letter, FDA has concluded that your work for InterChem is in violation of its final order of debarment, issued on November 5, 1993 (58 Fed. Reg. 59048). 21 U.S.C. § 335a(a)(2).

Under the final debarment order, you are prohibited from providing services in any capacity to a person with an approved or pending drug product application. 21 U.S.C. § 335a(c). The question of whether a person is providing services in any capacity to a person with an approved or pending drug product application does not turn on the presence of an immediate employer/employee relationship. The statutory prohibition includes any relationship which provides a debarred person with an opportunity for regular and frequent contact - and the related potential for influence - with the pharmaceutical industry. See Dicola v. FDA, 77 F.2d 504, 507, 509 (D.C. Cir. 1996).

Here, it is not sufficient to consider only whether your employer, InterChem, has approved or pending drug product applications. The pertinent query is whether InterChem provides services in any capacity to a person with such applications. InterChem provides services to the drug industry in that it assists in identifying drugs to be introduced into the generic market and locating companies to market such drugs. In addition, many of InterChem's suppliers and customers have drug product applications. For example, your employer, InterChem is the United States agent to ACS Dobfar, a company with numerous drug product applications. Based on the information available to FDA, your duties include assisting InterChem in evaluating active pharmaceutical ingredients to determine the intermediate chemicals needed for their manufacture. Your assistance to InterChem in this work causes you, through your employer, to provide services to a person with approved or pending drug product applications.

This letter is to inform you that your employment by InterChem Trading Corp. violates your debarment order. 58 Fed. Reg. 59048 (Nov. 5, 1993). Please advise FDA within 10 days of any action you have taken to correct this violation. Please send your response to:

                       Food and Drug Administration
                       New Jersey District Office
                       Waterview Corporate Center
                       10 Waterview Blvd., 3rd Floor
                       Parsippany, New Jersey  07054
                       ATTN: Diane E. Boucher, Compliance Officer

                                     and

                       Food and Drug Administration
                       Center for Drug Evaluation and Research
                       5600 Fishers Lane, HFD-7
                       Rockville, MD  20857
                       ATTN: Leanne Cusumano, Regulatory Counsel

A failure to take corrective action by terminating this employment relationship or by responding to this letter may result in the imposition of civil penalties, 21 U.S.C. § 335b, or other enforcement action.

Sincerely yours,

Douglas I. Ellsworth
New Jersey District Director