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.
Thursday, September 8, 2011
Update on CA e-Pedigree from Board of Pharmacy Meeting on Sept 7, 2011
On September 7, 2011 I attended a meeting of the full CA Board of Pharmacy, held in Los Angeles. One of the agenda items was an update on the state's e-Pedigree laws. There's not much new under the sun...and no new laws for the upcoming implementation of this program appear to be imminent. However, there are still some unresolved issues, mostly in the areas of technology, RFID and 2-dimensional bar code standards, the repository of the electronic pedigree database and other issues. So, some updates can be expected in the next couple of years.
CA's e-Pedigree is still going to be implemented on January 1, 2015...by that date manufacturers will be required to have an electronic product code on serialized containers for 50% of their products. The system will be phased in. Wholesalers are required to receive a pedigree starting on July 1, 2016 and on July 1, 2017 pharmacies will be required to receive a pedigree for prescriptions drugs that are received. After delays that have occurred every 2 years starting in 2007 and going to 2011, no further delays after 2015 are expected.
Executive Officer Virginia Herold and Deputy Attorney General Joshua Room gave an excellent overview presentation of the current state of pedigree statutes and requirements. A representative from the FDA also presented a talk on the federal government's support of CA pedigree model. Several reasons and justifications were given for the establishment of e-Pedigree. Among them are: drug diversion (increased in CA by 45% from 2008-2010), drug recalls, and drug counterfeiting.
However, there were some very apparent concerns. First, this board is not very knowledgeable in this area. The questions that were being asked by the members to the various presenters were questions that were asked and answered at the last update meeting on March 25, 2008. I was also at that meeting...it was disheartening to hear that not much progress or knowledge had increased. I believe that a better understanding of the drug distribution industry that they regulate is necessary.
Second, it was obvious to me and to most of the attendees that I talked with after the meeting...one of the primary goals of these laws is that they will be primarily used as an enforcement tool. They are also there to protect the public from counterfeit drugs, which was the primary reason that these laws exploded all over the country in the mid 2000's when counterfeiting became a huge 'business' and showed such dramatic increases. It believe that board members and staff sincerely have that as a goal, but drug counterfeiting was hardly discussed.
Instead, the first 2 reasons cited as benefits of e-Pedigree were diversion and drug recalls. Several cases of drug diversion by pharmacy employees, cargo thefts, and warehouse break-ins were cited. The infamous Chinese sourced Baxter Pharmaceuticals contaminated Heparin from 2008 was also discussed.
There a couple of problems with the logic used here. It is unknown how a bar code or an RFID tag on a bottle of Vicodin will prevent a pharmacy technician from diverting the drug from a pharmacy, it is also unknown how it will prevent a truck from being hijacked, and it certainly is not known how it would prevent a raw materials manufacturer in a foreign country from contaminating an Active Pharmaceutical Ingredient (which does not even require an e-Pedigree).
What will these laws do? When the board finds diverted or stolen dangerous drugs and/or controlled substances...an electronic product code on every bottle will tell them where it came from, who owned it and where it had been. I believe that brings a great deal of value to the industry. But it is not the initial reason that these laws were legislated. Back in 2004 and 2005, it was all about counterfeiting.
And, if these laws, once implemented, help capture criminals who divert, steal, contaminate or counterfeit dangerous drugs then I'm on board. They have my full support. More captures might result in less diversion, contamination and counterfeiting. But, let's call it what it is...it is an enforcement tool. The board is asking the industry to do much of the heavy lifting to assist in those enforcement efforts.
I welcome your comments,
Greg Evans, Pharm.D.
CA's e-Pedigree is still going to be implemented on January 1, 2015...by that date manufacturers will be required to have an electronic product code on serialized containers for 50% of their products. The system will be phased in. Wholesalers are required to receive a pedigree starting on July 1, 2016 and on July 1, 2017 pharmacies will be required to receive a pedigree for prescriptions drugs that are received. After delays that have occurred every 2 years starting in 2007 and going to 2011, no further delays after 2015 are expected.
Executive Officer Virginia Herold and Deputy Attorney General Joshua Room gave an excellent overview presentation of the current state of pedigree statutes and requirements. A representative from the FDA also presented a talk on the federal government's support of CA pedigree model. Several reasons and justifications were given for the establishment of e-Pedigree. Among them are: drug diversion (increased in CA by 45% from 2008-2010), drug recalls, and drug counterfeiting.
However, there were some very apparent concerns. First, this board is not very knowledgeable in this area. The questions that were being asked by the members to the various presenters were questions that were asked and answered at the last update meeting on March 25, 2008. I was also at that meeting...it was disheartening to hear that not much progress or knowledge had increased. I believe that a better understanding of the drug distribution industry that they regulate is necessary.
Second, it was obvious to me and to most of the attendees that I talked with after the meeting...one of the primary goals of these laws is that they will be primarily used as an enforcement tool. They are also there to protect the public from counterfeit drugs, which was the primary reason that these laws exploded all over the country in the mid 2000's when counterfeiting became a huge 'business' and showed such dramatic increases. It believe that board members and staff sincerely have that as a goal, but drug counterfeiting was hardly discussed.
Instead, the first 2 reasons cited as benefits of e-Pedigree were diversion and drug recalls. Several cases of drug diversion by pharmacy employees, cargo thefts, and warehouse break-ins were cited. The infamous Chinese sourced Baxter Pharmaceuticals contaminated Heparin from 2008 was also discussed.
There a couple of problems with the logic used here. It is unknown how a bar code or an RFID tag on a bottle of Vicodin will prevent a pharmacy technician from diverting the drug from a pharmacy, it is also unknown how it will prevent a truck from being hijacked, and it certainly is not known how it would prevent a raw materials manufacturer in a foreign country from contaminating an Active Pharmaceutical Ingredient (which does not even require an e-Pedigree).
What will these laws do? When the board finds diverted or stolen dangerous drugs and/or controlled substances...an electronic product code on every bottle will tell them where it came from, who owned it and where it had been. I believe that brings a great deal of value to the industry. But it is not the initial reason that these laws were legislated. Back in 2004 and 2005, it was all about counterfeiting.
And, if these laws, once implemented, help capture criminals who divert, steal, contaminate or counterfeit dangerous drugs then I'm on board. They have my full support. More captures might result in less diversion, contamination and counterfeiting. But, let's call it what it is...it is an enforcement tool. The board is asking the industry to do much of the heavy lifting to assist in those enforcement efforts.
I welcome your comments,
Greg Evans, Pharm.D.
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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