DEA Compliance

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The DEA issued a short press release yesterday that, at first glance, appeared to deliver on something that wholesale drug distributors have been seeking for years—access to ARCOS data so that wholesalers can see the total number of controlled substances a customer is ordering.* Despite the sensational headline, the new DEA tool is underwhelming and misses the mark because it will only tell a wholesaler how many other wholesalers a prospective customer has purchased a controlled substance from in the past six months. Unfortunately, this tool will provide little to no usefulness to distributors in identifying suspicious orders.

In a recently issued Request for Proposal (RFP) for Information Technology (IT) and other services in support of the Diversion Control Division, DEA indicated that it will be creating a new section in the Code of Federal Regulations. 21 C.F.R. 1301.78, will contain the suspicious order reporting requirement that is currently found in 21 C.F.R. 1301.74(b). DEA intends to define the term “suspicious order” with a list of specific factors to consider when scrutinizing an order. DEA is expected to require that the “presence of any one or more of these factors renders the order a suspicious order,” which must be reported to DEA via a secure network application for Suspicious Order Reporting System (SORS).

Pills and bottle

Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of course journalism and takes a strong position against drug companies. Aided by reporters from the Washington Post and former employees from the Drug Enforcement Administration (“DEA”), the 60 Minutes segment, while dramatic in its presentation, only told the facts relevant to the position it was taking – which is what makes good headlines.

The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia.

On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances.

Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017.

The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA).

An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be granted a new registration, but placed on probation for one year. Acting Administrator Chuck Rosenberg disagreed. He reviewed the case and concluded that DEA proved that the doctor knew the patient was abusing or diverting the drugs and prescribed anyway.  Dr. Wesley Pope’s application for a new DEA registration was denied as inconsistent with the public interest.

The Washington Post reported last week that it obtained sealed court documents describing how National Football League teams have violated federal prescription drug laws regarding the storage, tracking, transportation, and distribution of controlled substances. The documents—prepared by lawyers representing more than 1,800 former professional football players—include testimony and records that implicate all 32 NFL teams and a number of league personnel.

Plaintiffs filed Evans v. Arizona Cardinals Football Club, LLC in the U.S. District Court of Northern California in May 2015, after a federal judge dismissed a similar claim filed in state court (Dent v. Natl. Football League) on preemption grounds. Although the basis of the claims have long been public knowledge, the sealed documents cited in the article have renewed public interest by painting a detailed picture of alleged improper dispensing and overprescribing.

a rural mailbox chocked full of mail

We recently reported that the Drug Enforcement Administration (DEA) was changing its longstanding policy of allowing for a grace period for registrants who file an untimely application for renewal. This notice was posted on the homepage of DEA’s Office of Diversion Control’s website.

A Revised Announcement Regarding Renewal Applications is now posted on DEA’s website indicating that, except for one minor change, DEA is retaining its current policy and procedures regarding registration renewals. The announcement now reads:

Starting January 2017, DEA will no longer send its second renewal notification by mail. Instead, an electronic reminder to renew will be sent to the email address associated with the DEA registration.

reminder round orange grungy vintage isolated stamp

DEA recently announced a significant change to its registration renewal process.

For several years, DEA’s registration unit has allowed for a grace period for registrants who file an untimely application for renewal.  While DEA’s regulations do not contemplate such a grace period, registrants, especially individual practitioners, were allowed to keep their existing registration number — which was considered valid and active during the grace period — despite the failure to file a timely renewal application and despite multiple notifications from DEA.