DEA Chronicles

DEA Chronicles

Drug Enforcement Administration Compliance and Litigation Issues

DEA Announces New Ways for the Public to Dispose of Unused Controlled Substances

Posted in Drug Policy

Beginning next month, consumers will have an easier time getting rid of unused painkillers and other addictive drugs, which DEA hopes will discourage people from flushing the drugs down the toilet, throwing them in the garage, or leaving them, forgotten, in their medicine cabinets.  The new disposal methods include allowing people to drop off unwanted pills at pharmacies, some hospitals and long-term care facilities, and police stations.

DEA’s Final Rule, which implements the Secure and Responsible Drug Disposal Act of 2010 (“the Disposal Act”) by expanding the options to collect controlled substances back from ultimate users, is expected to be released tomorrow and will take effect on October 9.  The disposal methods include take-back events, mail-back programs, and drop-off locations.

The new regulations:

  • allow authorized retail pharmacies; hospitals and clinics with on-site pharmacies; manufacturers; distributors; reverse distributors; and narcotic treatment programs (NTPs), to place collection receptacles inside their establishments and to permit people to mail back unwanted controlled substance mediations;
  • expand the authority of authorized pharmacies and hospitals/clinics to place collection receptacles inside long-term care facilities; and
  • allow law enforcement agencies to place collection receptacles inside their stations, conduct drug take-back events, and administer mail-back programs. (Note that law enforcement agencies are not required to use collection receptacles that meet all of the specifications in the rule.)

DEA registrants that want to become controlled substances “collectors” will need authorization from the Agency to keep secure containers at their locations for controlled substances drop off or to conduct mail-back programs.  A registrant may seek to modify its DEA registration to become a collector by making a written request by mail or online.  Retail pharmacies and hospitals/clinics that become collectors will be allowed to put collection receptacles inside long-term care facilities for those facilities’ residents.

For security reasons, collection receptacles must be securely fastened to a permanent structure.  In addition, as a general rule, the collection receptacles must be placed in the immediate proximity of a designated area where controlled substances are stored and where an employee is present.  Hospitals/clinics, which would have difficulty meeting that requirement, must place receptacles in locations that are regularly monitored by employees and are not in the proximity of any area where emergency or urgent care is provided.

Collection receptacles must be accessible to the public because only the ultimate users of the drugs are authorized to place the controlled substances in a receptacle.  Pharmacy and hospital staff cannot take the drugs and put them into a container.

Registrants that choose to conduct mail-back programs must be able to destroy returned packages on site.  And registrants must provide customers with mail-back packages.  They can charge for the packaging, or provide the packaging for free.

The new rule permits controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances.

Other highlights of the Rule:

Methods of Destruction:

DEA is not requiring a specific method of destruction for controlled substances that are collected. Registrants are free to develop their own methods of destruction so long as, in the end, the drug is “non-retrievable”, which means the condition or state to which a controlled substance must be rendered following a process that permanently alters the controlled substance’s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes.  See 21 C.F.R. § 1300.05(b).  Once a controlled substance is “non-retrievable,” it is not longer subject to DEA requirements.

Long-Term Care Facilities:

In addition to allowing retail pharmacies and hospitals/clinics with on-site pharmacies to place collection receptacles in LTCFs for residents, DEA is also implementing special security requirements for these collection receptacles to encourage their use.

First, DEA is permitting sealed inner liners that have been removed from collection receptacles to be stored at LTCFs for up to three business days in a securely-locked, substantially constructed cabinet or in a securely-locked room with controlled access until the liners can be transferred for destruction.  However, DEA is encouraging authorized collectors to schedule inner liner removals on the same day that medications are delivered, if possible, to make storage of sealed inner liners unnecessary.

It is also important to note that collectors cannot transfer sealed inner liners from LTCFs to their registered locations (i.e., the pharmacy or hospital/clinic).  DEA is concerned that pharmacy or hospital/clinic employees transporting large quantities of controlled substances pose a security risk.  Therefore, collectors must deliver sealed inner liners to a reverse distributor or a distributor by common or contract carrier or by reverse distributor or distributor pick-up at the LTCF.

Second, collectors will be allowed to have one of its employees and a supervisory level employee of the LTCF (e.g., a charge nurse, supervisor, or similar employee) install, remove, store, or transfer inner liners, or the collector can have two of its own employees do the work.

DEA hopes that these modifications will result in expanded safe and secure disposal options for LTCF residents.

DEA Registrant Disposal:

DEA has modified DEA Form 41 and is requiring that the form to be used to record the destruction of controlled substances that remain in the closed system of distribution and to account for the destruction of controlled substances collected from consumers and other non-registrants pursuant to the Disposal Act.

Reverse Distributors:

DEA added a definition of “reverse distribute,” revised the definition of “reverse distributor”, and clarified that the security, inventory, and recordkeeping requirements for controlled substance destruction apply to some entities that reverse distribute even if they are not required to register as reverse distributors.

In addition, DEA has extended the time that a registrant that reverse distributes has to destroy controlled substances to 30 days, from the proposed 14 days.

Distributors may acquire controlled substances from collectors for the purpose of destruction, as a coincident activity to distribution.

The rules are intended to expand the options available to safely and securely dispose of potentially dangerous prescription medications on a routine basis.  Beginning in 2010, DEA has sponsored eight National Prescription Drug Take-Back events around the country that resulted in the collection of more than 4.1 millions pounds (over 2,100 tons) of medication at over 6,000 locations.

DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

Posted in Scheduling Actions

In 45 days, hydrocodone combination products (“HCPs”) will be Schedule II controlled substances.  This means that by early October, manufacturers, wholesalers, pharmacies, prescribers, and everyone in the drugs’ supply chains will have to be in compliance with the more restrictive regulatory requirements applicable to Schedule II drugs.

In a previous post we discussed whether the rescheduling of HCPs will have a meaningful impact on combating prescription drug abuse.

HCPs are drugs that contain hydrocodone, which by itself is a Schedule II, and another substance, such as acetaminophen or aspirin.  They are used to treat moderate to severe pain and to relieve cough.  Brand names include Vicodin, Lorcet, Norco, and Tussionex.  Last year, more than 137 million HCP prescriptions were dispensed.

Currently, HCPs were Schedule III controlled substances under federal law and in every state except New York, which moved them to Schedule II in February 2013.  Schedule II is reserved for drugs with the highest potential for harm and abuse, including psychological and physical dependence.

DEA is expected to publish its Final Rule in the Federal Register on this topic tomorrow, August 22, 2014, but a preview was made available today.

Some of the impacts of moving the drugs to Schedule II include:

  • Prescribing
    • Prescribers will not be allowed to authorize refills for HCPs, though they will be allowed to issue multiple prescriptions for up to a 90-day supply.
    • Note: DEA will permit pharmacies to dispense HCP refills after the effective date of the rescheduling if the prescription was issued before the effective date and the dispensing occurs before April 8, 2015.
    • Prescribers will not be able to fax or phone in prescriptions for HCPs, though verbal prescriptions will be allowed in emergency situations.
    • Mid-level practitioners in some states will lose the ability to prescribe HCPs or have their prescriptive authority limited, pursuant to state law.
  • Dispensing
    • In some states, pharmacists will have to count the prescriptions themselves because pharmacy technicians are not allowed to do so.
  • Ordering
    • Registrants will have to use official DEA Forms 222 to transfer HCPs, rather than simple invoices or packing slips.
  • Security
    • Manufacturers and wholesale distributors will have to store HCPs in vaults, rather than cages.
  • Labeling and Packaging
    • Manufacturers will be required to label every commercial container of HCPs, including all bottles, with a “C-II” designation.
    • DEA noted that the packaging and labeling requirements for manufacturers and distributors do not apply to dispensers. Thus, dispensers with HCPs in commercial containers labeled as Schedule III can continue to dispense them after the rescheduling takes effect.

Despite all of these changes, DEA rejected calls to delay the implementation of the new rules for two years, one year, or even six months, noting that scheduling actions are normally effective 30 days after publication of the Final Rule.  DEA acknowledged that HCPs are the most prescribed drug in the United States and that the supply chain “will need to plan and coordinate efforts, and may even need to temporarily modify existing ordering and inventory management practices.” But it concluded that it could not delay implementing the new rule beyond 45 days due to “the risk of diversion and risk to public health and safety of U.S. residents.”

DEA Decisions: In the Matter of Moore Clinical Trials, L.L.C.

Posted in DEA Final Orders

In the Matter of Moore Clinical Trials, L.L.C (July 11, 2014)

DEA last month denied the DEA research registration application of an Arkansas clinical research company, finding that the person who would be primarily responsible for ordering and storing controlled substances had a “shocking” lack of knowledge of the fundamental requirements imposed by the Controlled Substances Act and DEA regulations.

The case began in March 2011 when Greta B. Moore submitted a registration application on behalf of Moore Clinical Trials, the clinical research company she founded.  At the time, Ms. Moore had won a contract to participate in a long-term safety study that focused on the use of a Schedule II controlled substance.

Moore Clinical Trials’ application came under scrutiny from DEA diversion investigators because, among other things, Ms. Moore had no prior experience with handling controlled substances.  She had previously worked as a respiratory therapist and as a clinical research coordinator on clinical trials that did not involve controlled substances.  DEA eventually asked Ms. Moore to withdraw her application and, when she declined, an Order to Show Cause to deny the application as inconsistent with the public interest was filed on August 8, 2011.

Despite the Order to Show Cause, Ms. Moore forged ahead with Moore Clinical Trials’ work on the long-term safety study.  She aired TV commercials and placed qualified participants into the study.  She also brought on a DEA-registered doctor, Brian T. Nichol, who had previously been suspended by the Arkansas Medical Board for pre-signing controlled substances prescriptions and had been convicted of felony health care fraud in federal district court.

She would later testify, at the administrative hearing in September 2012, that she believed that Dr. Nichol could order the controlled substances, receive them at his office, and then dispense them to research participants at Moore Clinical Trials, which was an unregistered location.  She stated that she never asked the DEA diversion investigators with whom she was communicating about her application whether the doctor could lawfully transport the drugs from his registered location to her company’s office.

She also testified about inadequate records that she had created just weeks before the administrative hearing: “I’m sorry . . . but I don’t know anything about the true nature of creating these records.  My intent in creating these records was simply to have [the DEA Group Supervisor] affirm to me that I was on the right track. . . .So my main concern . . . was to attempt to be compliant with the DEA, so I’m simply creating forms, not for the DEA.  I didn’t realize that the DEA was going to get these forms.  The reason that the forms are not correct is because it was eleven o’clock at night when I did the forms.”

She went on to testify that she did know the record-keeping requirements for dispensing controlled substances, “but, as a compliant person, I’m more than happy to learn what is required as a DEA registrant, because I am prepared to do whatever needs to be done, as I do my clinical research, because there are requirements that are required there as well. So after I learn what is required . . . I’m fully prepared to be compliant.”

DEA Administrator Michele M. Leonhart called it “shocking” that even at the time of the hearing, Ms. Moore still lacked knowledge of several of DEA’s fundamental requirements.

Despite the testimony and other evidence, the ALJ recommended that Moore Clinical Trials’ application be granted on condition that Ms. Moore take a course in handling controlled substances.  While the ALJ concluded that Ms. Moore was responsible for signing for one controlled substances shipment when she was not registered to do so, the ALJ found that Ms. Moore was not responsible for the many controlled substances violations committed by Dr. Nichol.  The ALJ said he was an independent contractor to whom Moore Clinical Trials only offered “a facility in which to conduct research.”

Administrator Leonhart rejected the ALJ’s opinion and reasoning, calling it “counterfactual” and reflecting “a stunning misunderstanding of the CSA.”  The Administrator held that Dr. Nichol’s controlled substances violations should be imputed to Ms. Moore and her company because they aided and abetted his violations and that the violations “were clearly intentional”.  The Administrator further held that Ms. Moore and her company failed to maintain records as required by the CSA; that Ms. Moore failed to accept responsibility for the dispensing and record-keeping violations; and that Ms. Moore lacked candor in her testimony regarding the dispensing violations.  For all of these reasons, Administrator Leonhart, in her July 2, 2014 order, held that Moore Clinical Trial’s registration would be inconsistent with the public interest and denied the application.

DEA Decisions: In the Matter of Roy S. Schwartz, D.D.S

Posted in DEA Final Orders

In the Matter of Roy S. Schwartz, D.D.S (June 16, 2014)

DEA suspended for one year the DEA registration of a Tacoma, Washington dentist with more than 50 years experience after he admitted “sharing” his DEA number with another dentist who performed conscious sedation, and who had previously surrendered his DEA registration for cause.  DEA also ordered the dentist to complete a course in controlled substance record-keeping.

The Show Cause Order alleged that the dentist, Roy S. Schwartz, obtained controlled substances for another dentist, Raymond Wilkinson, with whom he shared office space.  Wilkinson, in turn, used the drugs to perform conscious sedation in Schwartz’s office, at other dentists’ offices, and at the University of Washington’s Periodontics Clinic.  Conscious sedation is the use of a combination of medicines that help a patient relax and block pain during a medical or dental procedure.  The Washington State Department of Health launched an investigation after receiving complaints that Wilkinson had used expired fentanyl and ketamine on patients.

Schwartz admitted that his secretary ordered the other dentist whatever controlled substances he needed and that Schwartz signed off on the orders.  He stated that the drugs were given directly to the other dentist and that the other dentist was responsible for the record-keeping of the drugs.  Wilkinson kept the drugs in a locked case in an unlocked cabinet in his office.

DEA Deputy Administrator Thomas M. Harrigan, in his June 2014 order, concluded that Schwartz’s continued registration was inconsistent with the public interest.  Harrigan found that Schwartz unlawfully distributed controlled substances to the other dentist, in violation of the Controlled Substances Act and DEA regulations, by using his DEA number to order the drugs and allowing them to be delivered, stored, and handled by the other dentist.  While this technically was diversion because the other dentist was unregistered and outside the close system of distribution, according to Deputy Administrator Harrigan, there was no evidence that the drugs were administered to patients other than in the course of legitimate dental treatment.

Schwartz also was found to have violated numerous DEA record-keeping requirements, including those in 21 U.S.C. §§ 827(a)(1); 827(a)(3); 842(a)(5); and 21 C.F.R. § 1304.11(b); 1304.21(a); 1304.22(b).

The Government had requested that Schwartz’s registration be revoked.  However, despite the fact that Schwartz’s statements showed that he had not accepted responsibility for his conduct and that DEA had a strong interest in deterring similar conduct by other registrants, Deputy Administrator Harrigan only suspended Schwartz’s registration for one year.  He cited Schwartz’s lack of previous controlled substances misconduct in more than 50 years of practice and Wilkinson’s use of the drugs to provide “legitimate dental treatment” as mitigating factors.

FedEx Pleads Not Guilty

Posted in DEA Compliance, Enforcement Actions

As expected, FedEx appeared in federal district court and entered a plea of not guilty to the charges brought against the company by the Drug Enforcement Administration (“DEA”) and the United States Attorney’s Office for the Northern District of California.  As we have recently discussed, this is an unprecedented action by the government seeking to hold a shipper responsible under the Controlled Substances Act (“CSA”) for the contents of packages delivered on behalf of its pharmacy customers.

While it is generally DEA registrants that must follow a litany of recordkeeping, reporting, security, and other obligations found in the CSA and DEA’s regulations, the government is alleging that FedEx knew or should have known that it was facilitating the unlawful diversion of controlled substances by shipping packages on behalf of its customers.  This case will ultimately turn on whether the Government can prove that lawful pharmaceutical products were being illegally prescribed and dispensed and, if so, whether FedEx, through its employees, knew that its delivery of packages from certain pharmacies was facilitating what the government has labeled as illegal Internet pharmacy diversion schemes.  The outcome will also hinge on FedEx’s resolve to challenge the government’s extraordinary action against the third-party logistics provider.  All indications thus far are that FedEx will not acquiesce and will continue to maintain its innocence and fight this through the criminal justice system.

It also appears that the government’s aggressive posture will continue as it seeks to present a superseding indictment to a grand jury later next month.

 

 

Image courtesy of Beck Gusler via Creative Commons

 

DEA Finalizes Rule to Schedule Tramadol

Posted in DEA Compliance, Drug Policy, Scheduling Actions

Possibly in the hopes of catching everyone before they leave for their 4th of July holiday, the DEA published its Final Rule in the Federal Register on July 2nd placing tramadol into Schedule IV effective August 18, 2014.  (Tramadol is a centrally acting opioid analgesic first approved for use in the U.S. in 1995 under the name “Ultram”.  Since then, the FDA has approved for marketing generic, combination and extended release versions.)  The DEA follows in the path of a number of states that have already taken this step such as Arkansas, Mississippi, and New York.  By making tramadol a Schedule IV controlled substance, the DEA makes it easier for the pharmaceutical industry to develop consistent policies and procedures nationwide for how this drug is handled.

Acknowledging that changes such as these take time to implement, the DEA extended the usual effective date for this type of change from 30 to 45 days to provide what it considers to be “reasonable time for registrants to comply with handling requirements for a schedule IV” drug, such as moving tramadol products into a warehouse cage or adjusting suspicious monitoring systems to include tramadol orders.  Though in the past the DEA has allowed for additional time for compliance or staggered the implementation process, it specifically chose to forgo staggered dates here to avoid confusion and inconsistent application of the new requirement.

It is important to note that as of August 18, 2014, manufacturers are required to print the designation “C-IV” onto every bottle and it is unlawful for commercial containers of tramadol to be distributed without that designation.  The DEA believes that the 45 day window between July 2nd and August 18th will “provide a reasonable time for distributors to sell existing stock” without the designation and to stock inventory with the proper designation.  Also, August 18th will be a busy day, as on August 18th every DEA registrant possessing tramadol must take an inventory of all tramadol stock in compliance with 21 C.F.R. §  1304.11(d).  Anyone who doesn’t want to handle controlled substances, but that currently stocks tramadol, must surrender the stock according to § 1307.21 or must transfer the stock to a DEA registrant before August 18th.

NABP Releases “Red Flags”

Posted in DEA Compliance

At the 110th Annual Meeting of the National Association of Boards of Pharmacy (“NABP”) a new educational video entitled “Red Flags” was released by NABP to assist pharmacists in properly exercising their corresponding responsibility and identifying the warning signs of prescription drug abuse and diversion.  The educational video was sponsored by Mallinckrodt Pharmaceuticals, Cardinal Health, McKesson Corporation, AmerisourceBergen, Actavis, and Endo-Qualitest Pharmaceuticals, all of whom are members of the Anti-Diversion Industry Working Group (“ADIWG”).  The companies worked with NABP to develop the concept and content for “Red Flags,” a video that uses real-life scenarios that illustrate the “moment of truth” when a pharmacist must decide whether a prescription for a controlled substance was issued for a legitimate medical purpose.  We have previously discussed the red flags of diversion.  “Red Flags” is an engaging and informative video that reinforces DEA’s statements about a pharmacist’s corresponding responsibility.  Industry initiatives like this will make a real difference in reducing prescription drug diversion and abuse since pharmacists are, as DEA has frequently stated, the “last line of defense” in preventing prescription drug abuse.

We applaud the NABP, Executive Director Catizone, Mallinckrodt Pharmaceuticals, Cardinal Health, McKesson Corporation, AmerisourceBergen, Actavis, and Endo-Qualitest Pharmaceuticals for working together to create “Red Flags.”

ADIWG is a consortium of leading pharmaceutical manufacturers and distributors of controlled substances who are working collaboratively and proactively to address the complex problems of prescription drug diversion and abuse.  Quarles & Brady is pleased that we have had the opportunity to assist the ADIWG in its efforts.  

Don’t Squeeze the Balloon: An International Perspective on Preventing Prescription Drug Overdoses

Posted in Drug Policy, Enforcement Actions, Overdose, Quota

Last year the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) published a paper on reducing opioid overdose mortality.  The paper addressed opioid overdoses related to heroin use and concluded that reduction in supply is an effective measure governments can take to reduce heroin overdoses.  The UNODC and WHO also addressed overdose incidents related to the misuse of opioid prescription drugs.  However, these organizations did not state, or even suggest, that reduction in supply of prescription narcotics would reduce opioid overdoses.  Instead the UNODC and WHO found that “[m]easures to limit the contribution of prescription medicines to opioid overdose include addressing the inappropriate prescription of opioids and other sedatives and inappropriate sales by pharmacies without a prescription.”

This approach to preventing overdose incidents with prescription narcotics makes perfect sense.  Supply is already limited by the Governments of countries which are Parties to the International Drug Control Conventions.  For example, in the United States, the DEA approves the importation of narcotic raw material used in manufacturing prescription opiates.  The Agency also establishes annual aggregate production quotas and assigns individual quotas to bulk and dosage unit manufacturers.  The problem with prescription drug abuse is not a failure to control supply.  Rather, it is the inappropriate prescribing of these drugs that fuels opioid addiction, abuse, and overdose incidents.  The ONDCP strategy to reduce prescription drug abuse will be more effective if it places a heavier emphasis on taking action to curb inappropriate prescribing of these drugs.

I was once an advocate for aggressively targeting the supply chain as a means of preventing the diversion and abuse of prescription drugs.  After all, targeting the supply chain is an effective law enforcement strategy for preventing the misuse of illicit drugs.  But the results of that strategy with prescription drugs have been ineffective as evidenced by the rising abuse of those products.  The governments of the world will continue to ensure adequate supply of pharmaceutical narcotics for medical purposes; therefore, effective enforcement must focus on the prescribers who inappropriately prescribe or over-prescribe these drugs.  Targeting the legitimate supply chain shifts, but does not solve, the problem.

Would focusing law enforcement efforts on prescribers rather than the entire supply chain be more effective at preventing prescription drug abuse?  We’d like to know what you think.

Defining, but Protecting, DEA’s Suspension Powers: the Impact of HR 4069

Posted in Drug Policy, Legislation

The “Ensuring Patient Access and Effective Drug Enforcement Act“ introduced by Representatives Blackburn and Marino defines the term “imminent danger.”  The Controlled Substances Act requires DEA to find that a registrant poses an imminent danger to public health or safety before the Agency can issue an immediate suspension order, but the current law does not define “imminent danger.”  DEA’s power to issue immediate suspensions is essential to protecting our communities and families from the harms of prescription drug abuse.  That power to suspend must be available to the Agency to abate truly imminent dangers that threaten the lives and health of the American public.

Because an immediate suspension has significant Due Process implications, the use of that power is confined to addressing imminent dangers.  As I indicated in testimony before the House Energy and Commerce Subcommittee on Health, defining imminent danger will protect and preserve this important power given to DEA.  In the absence of a clear legislative standard for suspensions, courts have shown a willingness to intervene.  I believe that establishing a clear standard for DEA to follow will better protect the public and will reduce legal challenges to immediate suspension orders.  Fewer legal challenges may not be good for the business of lawyers like me, but I’ll gladly trade business for real progress in protecting our communities from prescription drug abuse.

What do you think the impact of defining ”imminent danger” will be?

 

Congressional Hearing on CSA Amendment

Posted in Drug Policy, Legislation

Hearing on the Ensuring Patient Access and Effective Drug Enforcement Act

Today at 3 p.m., I will be joining DEA’s Mr. Joseph Rannazzisi, HDMA CEO John Gray and others to testify before the House Energy and Commerce Subcommittee on Health regarding a proposed amendment to the Controlled Substances Act.  H.R. 4069, introduced by Representative Tom Marino of Pennsylvania and Representative Marsha Blackburn of Tennessee, defines two key terms in the CSA — “imminent danger” and “consistent with the public interest” – as well as making other changes to strengthen efforts to prevent prescription drug abuse while enhancing patient access to controlled medications.  You can watch the hearing on the Ensuring Patient Access and Effective Drug Enforcement Act at 3 p.m … and stay tuned to DEA Chronicles for discussion of this bill.