Inspections, Compliance, Enforcement, and Criminal Investigations
Health Dimensions, Inc. Response Letter
July 31, 2007
BY FACSIMILE/CONFIRMATION COPY BY MAIL
Joann M. Givens
Detroit District Office
300 River Place, Suite 5900
Detroit, Michigan 48207
Re: Compounded Domperidone
Dear Ms. Givens:
I am writing in response to your letter of July 18, 2007 and to the District's Warning Letter of November 27, 2006 (No. 2007-DT-02).
We disagree with FDA's assertion that compounding domperidone medications from bulk API within the scope of the practice of pharmacy results in the creation of an unapproved new drug subject to the new drug provision of the Food, Drug, and Cosmetic Act.
We also take exception with FDA's characterization of safety concerns regarding the use of domperidone as applied to Health Dimensions' practices. Your letters mention safety concerns associated with the intravenous administration of domperidone and with the use of the drug by women to increase lactation. Health Dimensions has not compounded intravenous domperidone and does not compound domperidone for the purpose of increasing lactation. Indeed, our labels have clearly stated that our compounded domperidone medications are not intended to be used to increase lactation. We have dispensed compounded domperidone products pursuant to the receipt of prescriptions and orders from physicians seeking to treat patients suffering from gastroparesis and related serious gastrointestinal disorders for which in the physicians' professional judgment no alternative adequate treatments exist.
And while we understand that FDA encourages physicians who would like to treat patients suffering from gastroparesis with domperidone to first obtain an IND, we know of no legal basis for FDA's implied assertion that compounding pharmacies are somehow legally required to ensure that the physicians have complied with FDA's suggested course of action before dispensing the drug.
Please be advised that for business reasons, Health Dimensions has decided to phase out the practice of compounding domperidone from bulk API. We are concerned with the health and welfare of the patients we serve. Therefore, we will stop compounding domperidone from bulk API after we have dispensed one additional treatment cycle to our patients currently being treated with the medication in accordance with their physicians' instructions so that the patients and their physicians have adequate time to devise alternative courses of treatment. Our reasons for our decisions aside, we reiterate our-observation expressed in my letter to Judy Putz of December 20, 2006 that it is unfair for FDA to have publicly singled out Health Dimensions over the issue of compounding domperidone from bulk API while other similarly situated pharmacies continue the practice, to the best of our knowledge undisturbed by FDA.
In light of our business decision, we no longer see a need to meet with you and your staff to discuss this issue. We therefore respectfully ask that the meeting currently scheduled for August 8, 2007 be cancelled.
Scott Popyk, R.Ph., FIACP
Health Dimensions, Inc.
cc: Judith Putz, Compliance Officer
39303 Country Club Drive, A-26 - Farmington Hills, Michigan 48331
hdrx.com - Tel: (248) 489-1573 - Fax: (248) 489-1586