Effective April 1, 2022, California Board of Pharmacy (“BOP”) regulations no longer require reporting every single missing tablet or dosage form. Instead, the amended loss regulations establish thresholds which will reduce the number of reports received by the California BOP, and in our opinion, creates …
The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We blogged on the final 2016 guideline here on March 17, 2016). On February 10th, the agency published a comprehensive proposal …
The Drug Enforcement Administration (“DEA”) recently issued another Final Order revoking a pharmacy registration based on the failure of the pharmacy to meet its corresponding responsibility, more specifically, the failure to identify and resolve red flags. While the Final Order does not necessarily introduce any …
Last week the Drug Enforcement Administration (“DEA”) issued a direct final rule clarifying requirements about who may record the supplier’s DEA registration number on a single-sheet DEA Form 222 (“single-sheet form”). Clarification Regarding the Supplier’s DEA Registration Number on the Single-Sheet DEA Form 222, 86 …
The Drug Enforcement Administration (“DEA”) recently issued its final rule authorizing the use of mobile narcotic treatment programs (“MNTPs”) to allow registered Narcotic Treatment Programs (“NTPs”) employing mobile units to dispense medication for maintenance or detoxification treatment remotely. Registration Requirements for Narcotic Treatment Programs with …
This is the third in a series of posts on what DEA registrants can expect during cyclic and on-site inspections. Our series focuses on the background of such inspections, how investigators conduct them and how registrants should proactively prepare for and manage them. Part 1, …
Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. We are providing a post in three parts on …
Observers can be forgiven for thinking that the Drug Enforcement Administration’s (“DEA’s) primary focus is suspicious controlled substance orders or pharmacists’ “corresponding responsibility.” While these areas have been the subject of increased enforcement activity because of the national opioid epidemic, DEA registrants should not forget …
The Senate recently reintroduced legislation that would promote research into medical use of marijuana. The legislation would also importantly correct a deficiency in prior law and the Drug Enforcement Administration’s (“DEA’s”) recent rulemaking related to synthetically derived CBD. Marijuana remains classified as a schedule I controlled …
It seems as if the “hemp” debate has been raging forever. Yet only a little over two years have passed since enactment of the Agricultural Improvement Act of 2018, the “Farm Bill,” in December 2018 that amended the Agricultural Marketing Act of 1946 directing the …
More than four years ago the Drug Enforcement Administration (“DEA”) started down a path by issuing a policy statement asserting that the agency “fully supports expanding research into the potential medical utility of marijuana and its chemical constituents.” Applications to Become Registered Under the Controlled …
Apropos for the name of the great blues musician, Muddy Waters, the various federal, state and international classifications of cannabis and cannabis-derived substances is a complex scheme in search of the right rhythm. Cannabis and cannabis-derived substances are controlled within different schedules under the federal …
Cannabidiol (“CBD”) products are everywhere. They are sold in pharmacies, as well as grocery, health food and convenience stores, and over the Internet. To protect its citizens in the absence of federal requirements governing CBD and hemp-derived products for human consumption, the New York Department …
Recently, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking (“NPRM”) that provides much needed clarity on the requirements for how emergency medical services handle controlled substances. The NPRM would codify its regulations consistent with the Protecting Patient Access to Emergency Medications Act …
Owners and management of the Kilgoban Drug Company, a fictional prescription drug wholesaler in the fictional U.S. state of Moosissippi, are preparing to begin operations. They have applied for and obtained all of the licenses required to operate their business, including a wholesaler license issued …
