Q4 2008 / As States enter the medical gas compliance fray, businesses suffer
Ron Ball
B & R Compliance Associates LLC
ron.ball@brcompliance.com
As another new year approaches, it’s a good time to dust off
the crystal ball and take a look at the long-standing regulatory issues
that challenge the medical gas industry, especially the likely next
steps that will be taken in the coming months and the emerging paradigm
shift in our industry.
As of this writing, FDA has still not released the medical gas guidance document in its final form. However, although this project has been in progress since 2003, this does not mean that FDA has shelved it. This guidance document was on the agency’s official 2008 list of plans to be released to the public. This indicates that the medical gas guidance document appears to be officially on their radar. Conversations with key agency officials have confirmed that they are still committed to completing it.
The remaining barrier to FDA for the release of this document still
appears to be the requirements for stability testing and expiration
dating. FDA remains concerned about the potential for small cylinders
to leak while in long-term storage, and has discussed with CGA their
proposals to resolve the issue. The medical gas industry responded with
an alternative set of requirements, which the agency is still
evaluating. We remain hopeful that a compromise set of requirements can
be reached that address the key concerns of both groups. If not, we can
expect FDA to exercise its regulatory authority and settle the debate
itself.
Our industry will have to adapt and move forward accordingly. In a tough economy, footing the bill for new compliance requirements is even more of a challenge than ever, so continuing a dialogue with FDA on a workable set of requirements is in everyone’s interests. FDA’s office of Drug Manufacturing Product Quality, which has oversight of medical gases, has experienced some personnel changes in 2008, and this may have had some affect on completing the medical gas guidance document. Based on feedback from the agency to date, we fully expect that medical gas manufacturers will have to incorporate new requirements for stability/expiration date testing into their compliance programs. However, it is likely that any testing will be performed by CGA and submitted to FDA on behalf of its members, which relieves individual firms of this requirement and lets them conduct stability tests on their own products.
Primary Standard Controversy
Another issue with which we have been directly involved since 2005 is the development of new medical gas monographs by the United States Pharmacopeia (USP). Our industry has been in dialogue with this regulatory body, which has provided significant technical assistance in developing a workable set of standards. While it has required some time and effort, the interactions between CGA and USP have evolved into a solid working relationship. As a result of a series of face-to-face working meetings, the majority of the outstanding issues have been resolved – with the exception of reference or calibration standards.
Members of our industry have relied on NIST traceable gas standards for decades, whenever they set up and calibrated their medical gas analyzers. USP, on the other hand, is now proposing to establish USP-provided gas reference standards as the legal requirement for calibrating medical gas analyzers. While the application of USP-provided reference standards is a workable solution for other segments of the pharmaceutical manufacturing community, the implementation of this requirement in our world is a potential nightmare.
The unique properties of medical gases and its supply chain, will not fit easily into the traditional USP reference standard scheme. For example, USP does not currently plan to manufacture enough standards that would allow every gas manufacturer to purchase one. This could leave many firms scrambling to find the calibration gases they need to calibrate their analyzers and comply with the law. It also has still not been decided how our industry could subsequently gear up to supply a sufficient quantity of secondary standards that would permit medical gas firms to continue operating.
Secondly, our industry is facing a potential significant increase in costs for medical gas calibration standards. The medical gas industry is already under pressure from declining federal reimbursements for respiratory therapies, as well as increasing production and distribution costs. If we are forced to absorb this type of requirement, especially one that will do nothing to improve the safety or efficacy of our products, we are faced with a very un-palatable prospect. Resolving this issue promises to be the focal point of activity in 2009. Right now, the two parties are on different sides of the issue, and the prospects of a compromise appear cloudy.
Over the years, under CGA’s leadership, our industry has become increasingly adept at working with regulatory bodies to reach reasonable accommodations on issues. This is not to say that we have learned how to lobby regulators effectively – far from it. Our industry’s approach is to continue dialoguing with regulatory bodies, continue to educate those bodies on the issues that affect us most, and develop an understanding of their perspective, even when that process proves to be difficult. I am confident that we will continue to have on-going discussions with USP, and to explore options. Just how far that takes us toward reaching a solution that will not saddle our industry with costly or onerous requirements will remain to be seen in 2009.
The third issue I wanted to touch on is the emergence and increasing activities of individual state regulatory authorities in promulgating requirements for our industry. I have written previously about the Verified and Accredited Wholesale Distributor (VAWD) and e-pedigree initiatives working their way through different state legislatures. Now it appears that many states are proposing to adopt VAWD and e-pedigree together, as was recently the case in Wyoming. Other states, notably in the Midwest, have quietly adopted a version of e-pedigree requirements.
B&R has recently helped a number of distributors to adapt their procedures and forms to comply with these new requirements. Recently, Texas, and Maryland have proposed their versions of e-pedigree. While the industry has pursued exemptions for our industry, results to date are mixed. Some recent successes include getting California to grant a medical gas exemption from e-pedigree, as well as an exemption from VAWD in the state of Indiana. But we face an uphill state-by-state process to secure the same exemption granted in all 50 states.
In my opinion, the chances of our industry being successful in every state are low. This will then set the stage for the evolution of a patchwork approach to medical gas regulations that will end up with different requirements for each state. As a result, some medical gas firms that do business in multiple states may find that it is no longer feasible to sell medical gas es in adjacent geographical territories simply because of the difference in regulatory requirements and the high costs of compliance. Depending on the success we have in securing exemptions for medical gases to these requirements, I see this as a trend likely to begin emerging in the next 12 to 18 months.
States Forcing Paradigm Shifts
The emergence of the individual states as sources of regulatory activities that affect our industry is forcing a paradigm shift in how we stay abreast of and involved in emerging new compliance requirements. Dealing with regulatory authorities at the federal level has always been a challenging process for our industry. Adding an additional 50 regulatory groups in the form of state regulators and pharmacy boards, all creating new regulatory proposals, is simply outside the capabilities of CGA’s current processes and resources. We predict that our industry’s priority in 2009 will be to create a new set of work processes that will facilitate awareness of new regulatory proposals and how they affect our industry at the state level.
Unfortunately, signs point to a potential increase in the investment in manpower and the time required to keep abreast of regulatory proposals in the medical gas industry. We must adapt to this change in focus and develop appropriate mechanisms if we are to remain effective in responding and providing input to the regulatory proposals that affect FDA compliance. The crystal ball predicts that this will be the biggest challenge our industry will face in the coming months.
E-pedigree
The FDA in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act states that:
“A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.”
An e-pedigree (sometimes referred to as e-pedigree or electronic pedigree) is simply an electronic document which satisfies a pedigree requirement. The primary purpose of an e-pedigree is to protect consumers from contaminated medicine or counterfeit drugs.
On January 5th, 2007 EPCglobal ratified the Pedigree Standard as an international standard that specifies an XML description of the life history of a product across an arbitrarily complex supply chain.
As of 2008, most states have enacted some sort of pedigree requirement and many have also required e-pedigree. However, the existing e-pedigree requirements amount to little more than requiring that pharmaceutical supply chain companies be able to provide reports in formats such as pdf, text files, or spreadsheets.
The basic data elements of an original e-pedigree are:
Ron Ball
For more information on regulations that affect medical gas producers and end-users contact:
Ron Ball at B&R Compliance Associates LLC
+1 (317) 297-8518; e-mail:
ron.ball@brcompliance.com; go to: www.brcopliance.com
As of this writing, FDA has still not released the medical gas guidance document in its final form. However, although this project has been in progress since 2003, this does not mean that FDA has shelved it. This guidance document was on the agency’s official 2008 list of plans to be released to the public. This indicates that the medical gas guidance document appears to be officially on their radar. Conversations with key agency officials have confirmed that they are still committed to completing it.
The remaining barrier to FDA for the release of this document still
appears to be the requirements for stability testing and expiration
dating. FDA remains concerned about the potential for small cylinders
to leak while in long-term storage, and has discussed with CGA their
proposals to resolve the issue. The medical gas industry responded with
an alternative set of requirements, which the agency is still
evaluating. We remain hopeful that a compromise set of requirements can
be reached that address the key concerns of both groups. If not, we can
expect FDA to exercise its regulatory authority and settle the debate
itself.Our industry will have to adapt and move forward accordingly. In a tough economy, footing the bill for new compliance requirements is even more of a challenge than ever, so continuing a dialogue with FDA on a workable set of requirements is in everyone’s interests. FDA’s office of Drug Manufacturing Product Quality, which has oversight of medical gases, has experienced some personnel changes in 2008, and this may have had some affect on completing the medical gas guidance document. Based on feedback from the agency to date, we fully expect that medical gas manufacturers will have to incorporate new requirements for stability/expiration date testing into their compliance programs. However, it is likely that any testing will be performed by CGA and submitted to FDA on behalf of its members, which relieves individual firms of this requirement and lets them conduct stability tests on their own products.
Primary Standard Controversy
Another issue with which we have been directly involved since 2005 is the development of new medical gas monographs by the United States Pharmacopeia (USP). Our industry has been in dialogue with this regulatory body, which has provided significant technical assistance in developing a workable set of standards. While it has required some time and effort, the interactions between CGA and USP have evolved into a solid working relationship. As a result of a series of face-to-face working meetings, the majority of the outstanding issues have been resolved – with the exception of reference or calibration standards.
Members of our industry have relied on NIST traceable gas standards for decades, whenever they set up and calibrated their medical gas analyzers. USP, on the other hand, is now proposing to establish USP-provided gas reference standards as the legal requirement for calibrating medical gas analyzers. While the application of USP-provided reference standards is a workable solution for other segments of the pharmaceutical manufacturing community, the implementation of this requirement in our world is a potential nightmare.
The unique properties of medical gases and its supply chain, will not fit easily into the traditional USP reference standard scheme. For example, USP does not currently plan to manufacture enough standards that would allow every gas manufacturer to purchase one. This could leave many firms scrambling to find the calibration gases they need to calibrate their analyzers and comply with the law. It also has still not been decided how our industry could subsequently gear up to supply a sufficient quantity of secondary standards that would permit medical gas firms to continue operating.
Secondly, our industry is facing a potential significant increase in costs for medical gas calibration standards. The medical gas industry is already under pressure from declining federal reimbursements for respiratory therapies, as well as increasing production and distribution costs. If we are forced to absorb this type of requirement, especially one that will do nothing to improve the safety or efficacy of our products, we are faced with a very un-palatable prospect. Resolving this issue promises to be the focal point of activity in 2009. Right now, the two parties are on different sides of the issue, and the prospects of a compromise appear cloudy.
Over the years, under CGA’s leadership, our industry has become increasingly adept at working with regulatory bodies to reach reasonable accommodations on issues. This is not to say that we have learned how to lobby regulators effectively – far from it. Our industry’s approach is to continue dialoguing with regulatory bodies, continue to educate those bodies on the issues that affect us most, and develop an understanding of their perspective, even when that process proves to be difficult. I am confident that we will continue to have on-going discussions with USP, and to explore options. Just how far that takes us toward reaching a solution that will not saddle our industry with costly or onerous requirements will remain to be seen in 2009.
The third issue I wanted to touch on is the emergence and increasing activities of individual state regulatory authorities in promulgating requirements for our industry. I have written previously about the Verified and Accredited Wholesale Distributor (VAWD) and e-pedigree initiatives working their way through different state legislatures. Now it appears that many states are proposing to adopt VAWD and e-pedigree together, as was recently the case in Wyoming. Other states, notably in the Midwest, have quietly adopted a version of e-pedigree requirements.
B&R has recently helped a number of distributors to adapt their procedures and forms to comply with these new requirements. Recently, Texas, and Maryland have proposed their versions of e-pedigree. While the industry has pursued exemptions for our industry, results to date are mixed. Some recent successes include getting California to grant a medical gas exemption from e-pedigree, as well as an exemption from VAWD in the state of Indiana. But we face an uphill state-by-state process to secure the same exemption granted in all 50 states.
In my opinion, the chances of our industry being successful in every state are low. This will then set the stage for the evolution of a patchwork approach to medical gas regulations that will end up with different requirements for each state. As a result, some medical gas firms that do business in multiple states may find that it is no longer feasible to sell medical gas es in adjacent geographical territories simply because of the difference in regulatory requirements and the high costs of compliance. Depending on the success we have in securing exemptions for medical gases to these requirements, I see this as a trend likely to begin emerging in the next 12 to 18 months.
States Forcing Paradigm Shifts
The emergence of the individual states as sources of regulatory activities that affect our industry is forcing a paradigm shift in how we stay abreast of and involved in emerging new compliance requirements. Dealing with regulatory authorities at the federal level has always been a challenging process for our industry. Adding an additional 50 regulatory groups in the form of state regulators and pharmacy boards, all creating new regulatory proposals, is simply outside the capabilities of CGA’s current processes and resources. We predict that our industry’s priority in 2009 will be to create a new set of work processes that will facilitate awareness of new regulatory proposals and how they affect our industry at the state level.
Unfortunately, signs point to a potential increase in the investment in manpower and the time required to keep abreast of regulatory proposals in the medical gas industry. We must adapt to this change in focus and develop appropriate mechanisms if we are to remain effective in responding and providing input to the regulatory proposals that affect FDA compliance. The crystal ball predicts that this will be the biggest challenge our industry will face in the coming months.
E-pedigree
The FDA in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act states that:
“A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.”
An e-pedigree (sometimes referred to as e-pedigree or electronic pedigree) is simply an electronic document which satisfies a pedigree requirement. The primary purpose of an e-pedigree is to protect consumers from contaminated medicine or counterfeit drugs.
On January 5th, 2007 EPCglobal ratified the Pedigree Standard as an international standard that specifies an XML description of the life history of a product across an arbitrarily complex supply chain.
As of 2008, most states have enacted some sort of pedigree requirement and many have also required e-pedigree. However, the existing e-pedigree requirements amount to little more than requiring that pharmaceutical supply chain companies be able to provide reports in formats such as pdf, text files, or spreadsheets.
The basic data elements of an original e-pedigree are:
- Lot
- Potency
- Expiration
- National Drug Code and Electronic
- Product Code
- Manufacturer
- Distributor, Wholesaler or Pharmacy
- Unique identifier of the salable unit
Ron Ball
For more information on regulations that affect medical gas producers and end-users contact:
Ron Ball at B&R Compliance Associates LLC
+1 (317) 297-8518; e-mail:
ron.ball@brcompliance.com; go to: www.brcopliance.com
