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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…
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.…
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…
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…
  Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research. DEA says FDA analysis shows marijuana’s medical effectiveness has not been proven In a letter to the governors of Rhode…
In the Matter of the Medicine Shoppe (October 2, 2014) DEA recently revoked the registration of the Medicine Shoppe, a San Antonio, Texas,  pharmacy, based on a finding that the pharmacy violated the Controlled Substances Act in all of the following ways: dispensed controlled substances without a prescription; dispensed controlled substances when the prescription was “signed” using a signature stamp; allowed some customers to retain original controlled substances prescriptions; dispensed controlled substances when the prescription contained…
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
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…
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…