Inspections, Compliance, Enforcement, and Criminal Investigations
Bryant Ranch Prepack - Response 5/20/10
12623 Sherman Way Unit A
North Hollywood, CA 91605
Voice:(818)764-7225 Fax:(877) 277-7552
Director of Sales:Fred Ganjian RPH MS Extension 1
Sales Department Email: firstname.lastname@example.org
Director of Pharmacy: Kambiz Monem, Pharm D. Extension 2
President: Robert Mernick, Extension 3
Company Email: email@example.com
5/20/2010 12:05:00 PM
Daniel Cline, Acting Director
Los Angeles District Domestic Compliance Branch
U.S. Food & Drug Administration
Irvine, CA 92612
Dear Mr. Cline:
In Reference To W/L 13-10:
Dear Mr. Cline:
After a number of emails and telecoms between Mr. John Stamp, Compliance Officer (CO), LOS-DO, our staff and our outside FDA regulatory compliance consultant, we have concluded that it would be best to suspend packaging of any product which contains (b)(4) within our facility effective April 12, 2010.
We might at some future date obtain another unit in the industrial facility in which we are currently located and at that time submit drawings and procedures which would be in compliance with the CGMP. At this time we are willing to stipulate that we will no longer package any product which contains (b)(4), until we can get positive approval from the Food and Drug Administration.
It is our intention to continue to sell (b)(4) and (b)(4) drug products which are packaged in compliance of all CGMP standards at an FDA inspected facility. Until further notice we will be distributing to dispensing doctors (b)(4) which will be packed for us under our label by (b)(4). The labeling of these (b)(4) will list my firm as the distributor, and the name and address of both the repackager and original manufacturer. This repackager has indicated to us that they provide this same service to a number of other dispensing pharmacies such as our, which distribute to physicians who dispense prescription drug products to their patients. We will sell these products under the various wholesale pharmacy licenses which have been issued to us by (b)(4) states.
Regarding our particular type of pharmacy practices, providing repackaged drug products to physicians who then provide the medication to the patient in the course of their care, Mr. John Stamp CO, during a telecom with (b)(4) questioned whether this was an acceptable type of pharmacy practice. In response we would make reference to Title 21 CFR Section 207, which covers the exemption from FDA registration and drug listing. Of import with regard to our pharmacy practice is subsection “(a)”, which states: (a) Pharmacies that operate under applicable local laws regulating dispensing of prescription drugs and that do not manufacture or process drugs for sale other than in the regular course of the practice of the profession of pharmacy, including dispensing and selling drugs at retail. The supplying of prescription drugs by these pharmacies to a practitioner licensed to administer these drugs for his or her use in the course of professional practice or to other pharmacies to meet temporary inventory shortages are not acts that require pharmacies to register.
It is our position that the emboldened part of this subsection specifically covers our type of pharmacy practice. If we are exempt by the FDA from registration and drug listing, then it can only follow that the FDA recognizes our type of operations as acceptable State regulated pharmacy practice.
Also we would point out that though we have indeed registered and drug listed our products with the FDA, we have done so on a voluntary basis, the purpose of which was to obtain NDC codes for our products. The reason we have done this is that virtually all medical reimbursement entities (Insurance Companies, Medicare, and Medicaid) require NDC numbers on our products to obtain reimbursement.
At this juncture, since we believe we have addressed all the issues raised in the FDA Warning Letter, we would request the Warning Letter be closed on your web site. We also formally request the following:
• That all of our responses to said Warning Letter be posted along with it on the FDA Warning Letter website as soon as possible;
• That copies of all FDA test reports on all samples taken from our pharmacy be supplied to us as soon as possible;
• That an un-redacted (as much as is possible under FDA policy) copy of the Establishment Inspection Report associated with said Warning Letter also be supplied to us as soon as possible.
Robert Mernick, President, Bryant Ranch PrePack
John Stamp, CO, LOS-DO
Acting Branch Chief
Food and Drug Branch California Dept. of Public Health
1500 Capitol Avenue – MS 7602
PO Box 997413
Sacramento, CA 95899-7413