Originally published on Oct 31, 2018.

 

Continued political and public pressure has pushed sweeping changes to how the industry will transact Controlled Substance business.

Agenda for DOJ/DEA Rulemaking

1117-AB47: Suspicious Orders
From the DEA’s Proposed Rule “The Drug Enforcement Administration is proposing to revise its regulations relating to suspicious orders of controlled substances. The proposed rule defines the term suspicious order and specifies the procedures a registrant must follow upon receiving such orders.”
Analysis
The DEA has proposed to revise its suspicious order regulations. Most notably, these proposed revisions will include a definition of “suspicious order” and will lay out what DEA registration holders must do when they receive a suspicious order. Currently, the DEA regulations contain no hard definition of what constitutes a “suspicious order”. The regulations only state that “Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency”. This part of the proposed rule will surely be much appreciated by DEA registration holders in their efforts to monitor and identify “suspicious orders”.
What this means for the Industry:
This likely will be a positive for the industry, because it will help to give registrants a more clear and definitive idea of what exactly constitutes a “suspicious order”. Since the DEA has begun requiring suspicious order monitoring programs for registrants, the lack of a concrete definition for “suspicious order” has been a hurdle for registrants. Likewise, the lack of a detailed procedure for how to handle such orders when they were received has caused registrants uncertainty as well. Therefore, this change seems like it will be a benefit to registrants and help them to have a better idea of how exactly to comply with the DEA’s suspicious order requirements.
1117-AB45: Partial Filling of Schedule II Prescriptions
From the DEA’s Proposed Rule: “On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) of 2016 became law. One section of the CARA amended the Controlled Substances Act to allow a pharmacist, if certain conditions are met, to partially fill a prescription for a schedule II controlled substance when requested by the prescribing practitioner or the patient. The Drug Enforcement Administration is proposing to amend its regulations to implement this statutory change.”
Analysis
This proposed rule was made in response to CARA’s allowance of partial fillings of Schedule II prescriptions in specified circumstances. Once this rule goes into effect, it will allow these types of partial fillings to be legally made provided the outlined conditions are met. The DEA states that “the changes in this rule are also important in helping address the ongoing opioid epidemic, by allowing practitioners and patients to limit the amount of schedule II opioids left unused after a course of treatment.” As such, this rule seems promising and positive if it really can help to achieve some success in fighting the opioid epidemic, as the DEA claims.
What this means for the Industry:
The likely effect of this proposed rule on the inventory of Schedule II drugs would seem to be what the DEA has predicted: allowing prescribers and pharmacists to do partial fills of Schedule II substances would likely lead to there being less unused Schedule II drugs in circulation, this because patients would not be left with a surplus that may occur when a full fill would be more than was required to treat their condition. Whether this will have an effect on the opioid epidemic remains to be seen, but theoretically, it could have a positive effect as the DEA predicts, because there will not only be less unused Schedule II opioids to target for diversion but also presumably patients will not continue taking the surplus of opioids after they are necessary for their treatment and become addicted to them. However, at this time these effects are theoretical, so we will have to wait and see.
1117-AB44: New Format for DEA 222 Order Forms
From the DEA’s Proposed Rule: “The DEA is proposing to amend its regulations to implement a new format for order forms (DEA Form 222) which are issued by DEA to allow registrants to order schedule I and II controlled substances.  The new forms will replace the current triplicate carbon-copy forms utilized by the DEA.”
Analysis
As part of its slew of proposed new regulations, the DEA has also signaled that it intends to change the format for DEA Form 222. Currently, these forms are triplicate carbon-copy forms. The DEA has not indicated yet what the new format will be, but hopefully, it will result in a more streamlined format, which makes using Form 222 easier for registrants.
What this means for the Industry:
This could potentially have a positive impact on the industry. If the proposed rule helps to streamline the process and switch to a less cumbersome procedure for Form 222’s, it could save registrants time and frustration. However, with no details on what the new format will be, there is no way to tell if that is the case.
1117-AB49: Manufacturing Quotas
From the DEA’s Proposed Rule: “The Drug Enforcement Administration proposes to revise and amend existing regulations to reduce overall inventories held by DEA-registered manufacturers and other registrants; to create use-specific subcategories for procurement quotas; and to clarify the current language and ensure that both manufacturers and distributors are required to obtain certification of a buyer’s quota for the requested schedules I and II controlled substances, as well as list I chemicals.  These changes are necessary, in light of the increasingly complex controlled substances manufacturing business practices, to reduce the potential for the diversion of certain controlled substances.  Due to this evolution of complexity in the pharmaceutical industry and the inflexible nature of the regulations by which DEA must calculate inventory allowances for manufacturers of controlled substances, the current inventory allowances provide opportunity for the accumulation of controlled substance surpluses to occur.  These proposed regulations will rectify a situation where DEA’s ability to strike an appropriate balance between ensuring the availability of controlled substances to industry and the risk to public health and safety has been hindered and resulted in an overproduction of controlled substances inventories available for diversion.”
Analysis
This proposed change to the DEA regulations related to manufacturer quotas on production, inventory, etc. is not surprising considering the DEA’s steadily reduced quotas over the past few years for controlled substances. The proposed regulations seek to take aim at reducing built-up inventories of controlled substances, further refine the categories for quotas, and to further clarify existing language in DEA regulations, with the ultimate goal of striking a better balance between allowing manufacturers and other registrants to have access to the controlled substances they need and helping to prevent the diversion of controlled substances and the negative effect on public health that would have. This is a tall order for the DEA, but as no further details have yet been released on the language and content of the proposed regulations, it’s uncertain whether it will be able to rise to this challenge.
What this means for the Industry:
These new rules could potentially have a negative impact on registrants and the industry as a whole. If quotas continue to decrease, it limits the number of controlled substances available for manufacturers and registrants in general. If the quotas are more aggressive, this could cause there to be a shortage of controlled substances available, and inevitably it would affect the supply chain at all levels. However, if the quotas are more reasonable, it would be possible to offset some of those negative effects. The DEA has the difficult job of having to balance both the interest of the industry and of the public, so ideally this proposed rule would strike that balance. However, as the more in-depth details of how these new rules would work or how they would be formulated are unavailable at this time, there is no way to know for certain what effect this would have on the industry.
1117-AB36 : Proper Service of Orders to Show Cause
From the DEA’s Proposed Rule: “The DEA proposes to amend its regulations to clarify the DEA’s obligation to ensure proper service of orders to show cause issued in connection with its administrative enforcement proceedings, and to conform its regulations with other Federal agencies that authorize a default finding where no response to the order to show cause is received notwithstanding legally sufficient service.”
Analysis
These proposed regulations appear to be an attempt by the DEA to further streamline procedures related to orders to show cause and to bring its procedures in line with other Federal agencies
What this means for the Industry:
This should likely be a positive because it will help registrants have a better understanding of the DEA’s procedural obligations related to show cause orders and it will help make DEA’s procedures conform with those of other Federal agencies, which should help to reduce the frustration of registrants of having to deal with DEA-specific procedures in the area covered by the proposed regulation.
1117-AB40: Telemedicine Registration for Controlled Substance Distribution and Dispensing
From the DEA’s Proposed Rule: “The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) (Pub. L. 110-425) was enacted on October 15, 2008, and amended the Controlled Substances Act by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. Among other things, the Act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the Internet, except in the case of practitioners engaged in the practice of telemedicine. The definition of the ‘‘practice of telemedicine’’ includes seven distinct categories that involve circumstances in which the prescribing practitioner might be unable to satisfy the Act’s in-person medical evaluation requirement yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. One specific category within the Act’s definition of the ‘‘practice of telemedicine’’ includes ‘‘a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].’’ 21 U.S.C. 802(54)(E). The Act also specifies certain criteria that DEA must consider when evaluating an application for such registration. However, the Act contemplates that DEA must issue regulations to effectuate this special registration provision. The DEA proposes to amend the registration requirements to permit such a special registration.”
Analysis
This proposed regulation is merely the DEA formally acting to fulfill its requirements under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 to formally create a telemedicine registration. As telemedicine becomes a more popular business model, this new form of registration will likely be much appreciated by the telemedicine community.
What this means for the Industry:
This will likely be a positive for the industry (of the telemedicine sector particularly) because it will formally allow telemedicine practitioners to obtain DEA controlled substance registrations. This will allow those practicing telemedicine to more easily serve their patients and still be in compliance with the Ryan Haight Online Pharmacy Consumer Protection Act of 2008.
1117-AB05: Sellers of Scheduled Listed Chemical Products 
From the DEA’s Proposed Rule: “This rule would modify and finalize the interim-final retail provisions of the Combat Methamphetamine Epidemic Act of 2005 (CMEA) (title VII of Pub. L. 109-177). Final provisions may include daily and 30-day sales limits for covered products to individuals, packaging limits, product placement requirements (behind the counter), requirements for regulated sellers to check the identity of purchasers and to maintain a log of each sale that includes the purchaser’s name and address, and requirements for regulated sellers to train employees in the provisions of the law and to certify to DEA that such training has occurred.”
Analysis
This proposed rule finalizes the DEA’s interim rules on the retail requirements of the CMEA and outlines the provisions that registrants should expect to find included.
What this means for the Industry:
This should be a positive in the sense that it will bring better clarity and certainty for registrants as this rule constitutes a final form of the retail provisions, so unlike before, at this point, these provisions will be final and not merely interim, meaning they are unlikely to majorly change any time in the near future. Although it may cause a burden on some registrants by requiring them to make changes so that they can conform with the requirements for Listed Chemical Products, such as product placement requirements, the identity verification, and logging requirements, etc. Although, because this rule would only finalize the interim provisions, it likely will not be as much of a burden for most of those registrants covered, as they should have already been in compliance with the requirements in the interim rule.

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