Dear President Trump,

For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There have been many solutions put forth in the past several months. These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing of controlled substances. Mr. President, this is a unique opportunity for you to reset our approach to this crisis. As a first step, we need to reassess the enforcement-first approach of the past several years.
Continue Reading An “Open Letter” to President Trump Regarding the Prescription Drug Abuse Epidemic

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).
Continue Reading Oregon Adds Suspicious Order Reporting to Wholesale Distributor Requirements

On November 13, 2015, the DEA issued its final decision and order in the case against Perry County Food & Drug (“PCFD”). The Administrator denied PCFD’s pending application to renew its registration based on stipulations by PCFD that its pharmacist-in-charge, who happened to be the son of PCFD’s owner, created and filled fraudulent prescriptions and committed numerous other acts that each amounted to “an outright drug deal.” The Administrator also found that the owner was informed of his son’s diversion activities on multiple occasions by long-standing employees and other family members. With facts like these, the Administrator’s order denying PCFD’s application is not surprising. But the decision is noteworthy for its clarification of DEA precedent concerning “community impact.”

“Community impact” is a factor that respondents have raised to turn the Agency’s “public interest” determination on its head: instead of focusing on whether the respondent’s registration is inconsistent with the public interest, this factor looks at whether the revocation of the respondent’s registration would be inconsistent with the public interest. But when PCFD made its community impact argument based on Pettigrew Rexall Drugs, the CALJ summarily dismissed the argument as having been “rendered irrelevant by Agency precedent,” citing to several cases involving a physician or dentist.
Continue Reading DEA Decisions: Community Impact Factor Still Relevant to Pharmacy Registrations

Corresponding responsibility is perhaps one of the most commonly misunderstood and/or (unfortunately) unknown concepts found in DEA’s regulations.  And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility.  I have had countless conversations with practicing pharmacists who are either unfamiliar with the concept of a “corresponding

The DEA has announced an upcoming Manufacturer/Importer/Exporter Conference to be held in June 2013 at the National Harbor, Gaylord National Resort & Convention Center. “The purpose of this conference is to provide a forum to present federal laws and regulations that affect the pharmaceutical and chemical manufacturing, importing, and exporting industry and to discuss practices