From: Kendall, Poppy
Sent: Tuesday, November 04, 2003 9:25 AM
To: Dockets, FDA
Cc: Butler, Jennie C
Subject: FW: For Docket 2003N-0361 Anti-Counterfeit Drug Initiative

Please add the comment below to the 2003N-0361 Docket. It was received in time, however the commenter forwarded it to me rather than the docket.
Thanks,
Poppy Kendall
Office of Policy, Office of the Commissioner



__________________________________________________________
Docket No. 2003N-0361

To: The FDA Anti-Counterfeiting Task Force
From: Patrick M. Schmidt, President and CEO, FFF Enterprises Inc., 800-843-7477
Re: Anti-Counterfeiting and Best Drug Distribution Practices
Date: November 3, 2003

At the request of the FDA participants at the October 15, 2003 public meeting on the Anti-Counterfeit Drug Initiative, FFF Enterprises is submitting our Best Drug Distribution Practices to Docket No. 2003N-0361. We thank you for the opportunity to contribute to the important work of the FDA's Anti-Counterfeiting Task Force.

FFF Enterprises Best Drug Distribution Practices:
Guaranteeing Supply Channel Integrity

FFF Enterprises, a biopharmaceuticals distributor, operates under the belief that a well-defined, responsible distribution channel is essential to protect pharmaceuticals from entering the gray market and, consequently, from its risks - counterfeiting, mishandling and tampering.

FFF has adopted the following practices over the last 15 years to assure a secure supply channel: 

1.	We purchase pharmaceuticals only from manufacturers. We do not
purchase drugs from secondary wholesalers or distributors.

	(Currently, the process to become an authorized distributor varies by manufacturer, and in most cases is defined simply by a distributor's willingness to purchase pharmaceuticals, rather than by the quality of the distributor's practices.)

2.	We sell drugs only to authorized healthcare providers (hospitals,
pharmacies, homecare companies, physician offices and clinics) or directly to the consumer, per a physician's prescription, via our licensed specialty pharmacy.

3.	From the moment of FFF's receipt of product, each vial's lot number
is tracked electronically, with FFF's patented Lot-TrackŪ (U.S. Patent # 6,611,806 lot-tracking system for pharmaceuticals). Each vial that leaves our facilities is tracked to the receiving healthcare provider or consumer. 

	Lot-Track's functions include automated notification of affected customers within four hours of FFF's receipt of notice of recalls, withdrawals, look-backs and other product safety actions. Lot-Track data is maintained in perpetuity to assure comprehensive notification.

4.	FFF stores drugs in a licensed, secured, temperature-controlled
environment.

5.	We scrutinize every customer order to confirm appropriate state
and/or federal licensure and to assure the customer's legitimacy (see #2). We will not sell to another distributor.

6.	FFF employees responsible for the handling of pharmaceuticals in our
storage and distribution facilities are state certified.

7.	We meet or exceed all manufacturer requirements for product
management. Each product is stored, packed and shipped according to manufacturer specifications. Specialized packaging for temperature controlled shipping is validated, based on Control Temp Packaging specifications.


To complete the secure supply channel, expansion to the industry of FFF's Best Drug Distribution Practices requires industry acceptance of the practices described above and shared responsibility for implementation:

1.	Because there is no existing certification authority, manufacturers
will establish a common standard for certifying authorized distributors, and publish current lists of authorized distributors for public reference.

2.	Distributors will establish a common standard for certifying
qualified customers.

3.	Customers will purchase drugs only from manufacturer authorized
distributors.


I want to thank you again for the opportunity to participate in the important work of the Anti-Counterfeiting Task Force. We stand ready to help implement expansion of FFF's Best Drug Distribution Practices throughout the pharmaceutical distribution industry.