Saturday, October 16, 2010
Wednesday, May 26, 2010
Warehouse and Cargo Thefts - increased FDA activity
ALERT!! In the wake of the recent warehouse theft of $75 million and with the prevalence of more and more prescription drug cargo thefts, the FDA has sent a letter to licensed drug manufacturers and wholesalers in an effort to urge the industry to take additional steps for prevention of such occurrences. This theft occurred March 24, 2010 at the Enfield, CT Eli Lilly distribution center shortly before midnight on a Saturday night. It was not discovered until after 2pm on Sunday, over 14 hours later.
We believe that this will bring the issue of warehouse and cargo security very high on the radar of inspectors from state boards, the FDA and other regulatory authorities. Prudent action would indicate each licensed facility to take the time and effort to ensure that your facility has adequate security, especially during "off" hours.
It also provides an opportunity to review your facility policies and procedures regarding shipping of prescription products...and the protection against theft and diversion that surrounds that phase of distribution.
To read the entire text of the letter please go to the following link:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209911.htm
Here is the introduction to that FDA letter:
The U.S. Food and Drug Administration today sent a letter to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products.
The products stolen have included prescription and over-the counter medicines, medical devices, and infant formula.
In its letter, the FDA seeks to:
~ raise awareness among industry about each firm’s responsibility to review and strengthen their security practices
~ inform industry of the actions the FDA will take when the agency becomes aware of a large-scale theft, and outlines steps that firms should take
~ emphasize the importance of notifying and informing members of the supply chain and the public after thefts occur. The FDA believes every company should have a clear plan developed on how to respond to these incidents, since swift action is essential.
The agency believes prevention of cargo theft is critical. To help achieve that goal, the FDA will continue to work closely with manufacturers and wholesalers to find ways to better secure the nation’s supply chain, which protects the public health.
We believe that this will bring the issue of warehouse and cargo security very high on the radar of inspectors from state boards, the FDA and other regulatory authorities. Prudent action would indicate each licensed facility to take the time and effort to ensure that your facility has adequate security, especially during "off" hours.
It also provides an opportunity to review your facility policies and procedures regarding shipping of prescription products...and the protection against theft and diversion that surrounds that phase of distribution.
To read the entire text of the letter please go to the following link:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209911.htm
Here is the introduction to that FDA letter:
The U.S. Food and Drug Administration today sent a letter to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products.
The products stolen have included prescription and over-the counter medicines, medical devices, and infant formula.
In its letter, the FDA seeks to:
~ raise awareness among industry about each firm’s responsibility to review and strengthen their security practices
~ inform industry of the actions the FDA will take when the agency becomes aware of a large-scale theft, and outlines steps that firms should take
~ emphasize the importance of notifying and informing members of the supply chain and the public after thefts occur. The FDA believes every company should have a clear plan developed on how to respond to these incidents, since swift action is essential.
The agency believes prevention of cargo theft is critical. To help achieve that goal, the FDA will continue to work closely with manufacturers and wholesalers to find ways to better secure the nation’s supply chain, which protects the public health.
Friday, April 16, 2010
Do California Drug Manufacturers need to be licensed as wholesalers?
In some cases yes. CA law in BP 4160(f) states: A drug manufacturer premises licensed by the FDA or CA FDB that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section (wholesaler licensing) and from Section 4161 (Non-Resident Wholesaler Licensing).
Interpretation: If you are a drug manufacturer and you are shipping drugs that you manufacture from the same address which they are manufactured at, then you do not need to be licensed as a drug wholesaler or a non-resident drug wholesaler in California.
If, on the other hand, you are storing products in a separate distribution center or with a 3rd party logistics company (3PL) and negotiating their shipping from those facilities, then you are required to be licensed as a drug wholesaler or non-resident drug wholesaler in CA. Most of the "virtual" manufacturers fall into this category.
The separate DC or 3PL also needs to be licensed as a wholesaler and each facility must have a CA licensed Designated Representative on the premises. The DR is responsible for the facility's compliance with all applicable laws.
Interpretation: If you are a drug manufacturer and you are shipping drugs that you manufacture from the same address which they are manufactured at, then you do not need to be licensed as a drug wholesaler or a non-resident drug wholesaler in California.
If, on the other hand, you are storing products in a separate distribution center or with a 3rd party logistics company (3PL) and negotiating their shipping from those facilities, then you are required to be licensed as a drug wholesaler or non-resident drug wholesaler in CA. Most of the "virtual" manufacturers fall into this category.
The separate DC or 3PL also needs to be licensed as a wholesaler and each facility must have a CA licensed Designated Representative on the premises. The DR is responsible for the facility's compliance with all applicable laws.
Thursday, April 15, 2010
Welcome To Our Blog!
Welcome to our Designated Representative blog for drug wholesalers and manufacturers! Providing a place for our seminar attendees to come to get updated information has been a long time coming. We'll be providing periodic updates and happenings in the drug distribution and manufacturing industry. We will highlight new laws, enforcement issues as well as provide some general info and about what is happening in the ever-changing and challenging environment of drug distribution.
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