Today, Medscape Pharmacists News reported that lawmakers at the US federal level did no agree on a national plan for tracking medications. Medscape stated that failure to come to an agreement is "crimping efforts to protect the U.S. Supply chain from the threat of counterfeit or stolen drugs".
After a last minute effort over last weekend to work out the details of the plan, the Senate and House of Representatives "conceded defeat in trying to include the measure in a 'must-pass' funding bill for the FDA.
The article went on to state that many stakeholders, including regulatory agencies and private companies have been working on a 'track and trace' system for about 10 years, but no agreement can be made as to how the plan will work or who will pay for it.
Congressional staffers have been quoted as stating that some lawmakers may try to introduce the measure as a stand-alone bill later this year, but this was also tried in the last Presidential election cycle in 2008. That bill (HR5839) failed to make it out of committee. This year, we have a divided Congress, which will make it even tougher in 2012.
The Senate version of this current FDA bill required a uniform "drug tracing system". But a newer draft was proposed last Friday that lawmakers could not get agreement on "how quickly the U.S. would move toward a 'unit-level' system that tracks individual drug packages". The timeline was very long, and it was not clear if it would ever even happen. Hence, the measure died.
The article mentioned the California Pedigree law which was passed in 2004, appeared in the 2005 California Pharmacy Law Book and whose first phase is currently scheduled to be implemented in 2015, after multiple delays.
Access Pharmacy Resources CA Designated Rep Seminar instructor, Greg Evans, Pharm.D., started teaching these California laws when the legislation was making its way through the CA legislative bodies in 2004. If you need the most current information on CA Pedigree laws, contact us here at APR and we can give you everything you need.
Stay tuned...our ear is always close to the ground.
Tuesday, June 26, 2012
Monday, April 2, 2012
FDA Finally Toughens Up On Drug Cargo Thefts
On March 23, 2012 the FDA issued a new Standard Operating Procedure (SOP) on Cargo Thefts. We have previously addressed this issue back in May of 2010 when the federal agency issued a warning letter alerting stakeholders in the increasing incidence of these thefts.
As a result of the spectacular March 2010 break-in and theft of over $75 million in drug products from an Eli Lilly warehouse in Enfield, CT most drug manufacturers and wholesale distributors beefed up security to help prevent future occurrences.
In the release of these new SOP's, the FDA wants to ensure that the industry is aware of the reporting obligations when a theft occurs, not only from a licensed warehouse facility but also when prescription drug products are being shipped. It is during the shipping process that these cargos are at their most vulnerable.
The SOP states that "if a firm is non-responsive to FDA's request for information related to the cargo theft or if the firm's action plan is inadequate, or if the firm is unwilling or reluctant to alert the public to the cargo theft, the [FDA's] Cargo Theft Response Team will consider the option of providing the public with the relevant facts about the cargo theft and to address the public health risk associated with that theft".
In other words...they are going to publicly embarrass you. Since the FDA doesn't really have specific licensing jurisdiction over most wholesalers (that is handled by the states), that's about all they can do. But if you don't think that they will notify YOUR licensing agency when you report a theft to them...have some more coffee, you might not be awake yet.
Take steps to secure your product TODAY! Protect that which is in your building, and that which is on the road, either on your own vehicles or with a 3rd party shipper. Have talks with your shippers about security, review your contracts with them to see how they handle a security breach. Are you financially liable, or are they?
There is a great deal of valuable information from FreightWatch International about pharmaceutical cargo thefts at:
http://www.freightwatchintl.com
And, you may read this FDA SOP about Cargo Theft at this link:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM297208.pdf
Until next time...be safe and keep your drugs safe!
Greg Evans, Pharm.D.
As a result of the spectacular March 2010 break-in and theft of over $75 million in drug products from an Eli Lilly warehouse in Enfield, CT most drug manufacturers and wholesale distributors beefed up security to help prevent future occurrences.
In the release of these new SOP's, the FDA wants to ensure that the industry is aware of the reporting obligations when a theft occurs, not only from a licensed warehouse facility but also when prescription drug products are being shipped. It is during the shipping process that these cargos are at their most vulnerable.
The SOP states that "if a firm is non-responsive to FDA's request for information related to the cargo theft or if the firm's action plan is inadequate, or if the firm is unwilling or reluctant to alert the public to the cargo theft, the [FDA's] Cargo Theft Response Team will consider the option of providing the public with the relevant facts about the cargo theft and to address the public health risk associated with that theft".
In other words...they are going to publicly embarrass you. Since the FDA doesn't really have specific licensing jurisdiction over most wholesalers (that is handled by the states), that's about all they can do. But if you don't think that they will notify YOUR licensing agency when you report a theft to them...have some more coffee, you might not be awake yet.
Take steps to secure your product TODAY! Protect that which is in your building, and that which is on the road, either on your own vehicles or with a 3rd party shipper. Have talks with your shippers about security, review your contracts with them to see how they handle a security breach. Are you financially liable, or are they?
There is a great deal of valuable information from FreightWatch International about pharmaceutical cargo thefts at:
http://www.freightwatchintl.com
And, you may read this FDA SOP about Cargo Theft at this link:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM297208.pdf
Until next time...be safe and keep your drugs safe!
Greg Evans, Pharm.D.
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