This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
The Federal ControlledSubstances Act (“CSA”) and its regulations require Drug Enforcement Administration (“DEA”) registrants to submit certain reports related to narcotic drug transactions, thefts and significant losses, and suspicious orders. They do not know that controlledsubstance reporting isn’t just for DEA anymore.
Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlledsubstances. On October 10th, based on ability to pay, the U.S. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.
While the presence of a dispensing red flag does not prohibit a pharmacist from filling a controlledsubstance, it means that there is a potential concern with the prescription, which the pharmacist must address andmake a record of its resolution, assuming it is resolvable.
Houck — The Drug Enforcement Administration’s (“DEA’s”) February 13th determination that THC acetate ester (“THCO”) is a schedule I controlledsubstance under the federal ControlledSubstances Act (“CSA”) has received a good amount of attention in the cannabis press. By Larry K. 51639, 51641 (Aug.
Department of Health and Human Services (HHS), based on the federal ControlledSubstances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Schedules of ControlledSubstances: Rescheduling of Marijuana, 89 Fed. By Larry K.
Houck — If a patient presents a paper prescription for a controlledsubstance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V ControlledSubstances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.
Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlledsubstances. DEA’s proposed rule when finalized would authorize telemedicine pursuant to the ControlledSubstances Act, 21 U.S.C. § By Karla L.
CARA amended the ControlledSubstances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).
We also note there are states where marijuana remains the equivalent of a schedule I controlledsubstance. Separate and apart from the loosening of marijuana restrictions by these states, marijuana remains a schedule I controlledsubstance under federal law.
Interested persons,” that is “any person adversely affected or aggrieved by any rule or proposed rule issuable” under the ControlledSubstances Act wishing to participate in the hearing must file a written notice of their intention to participate, which DEA will review.
(IMC Pro), a shipping and logistics company based in North Carolina, agreed to pay $400,000, not a significant amount compared to some recent settlements, but not chump change either, to resolve allegations that it violated the ControlledSubstances Act for transshipping precursor chemicals. of 1-BOC-Piperidone and 138.66
These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. We will discuss the state of relevant laws prior to our new “COVID reality” and telemedicine issues during and post-pandemic, both with respect to the prescribing of controlledsubstances and non-controlled drugs.
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks! Join our co-chairs Kurt R.
An Immediate Suspension Order is served along with an Order to Show Cause, allowing you to challenge DEAs determination that your registration should be revoked, but it takes away your ability to handle controlledsubstances while your case is pending.
Attorney’s press release observes, it is a stark reminder that registrants are “ultimately responsible for supervising all personnel on the premises and preventing the diversion of controlledsubstances.” Company Pays $158,760 to Resolve Claims Related to ControlledSubstance Thefts From Pharmacies During Inventory, U.S.
Comments ranged from single sentence declarations to lengthy, cogent treatises, expounding on whether to reschedule marijuana from schedule I to schedule III or another schedule under the federal ControlledSubstances Act (“CSA”), to leave marijuana in schedule I, or to deschedule altogether. 21 U.S.C. § 812(c)(c)(10). 21 U.S.C. §
Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlledsubstances, which were originally set to expire after the end of the COVID-19 pandemic emergency.
District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlledsubstances “by filling prescriptions while ignoring red flags.” The Government alleged that Coconut Grove violated numerous federal and state controlledsubstance laws. By Larry K. 21 U.S.C. §
Houck — Perhaps you obtain controlledsubstance quotas or submit ARCOS reports? DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlledsubstance and listed chemical requirements in Houston on May 2-4, 2023. By Larry K.
Houck We appreciate receiving feedback on our blog posts. By Larry K. We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice.
Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlledsubstances and buprenorphine. part 1306 (which include DEA’s general requirements for prescribing controlledsubstances); 88 Fed. By Karla L. 1307.41and 42 C.F.R.
As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing controlledsubstances generally, and for buprenorphine use in opioid treatment. HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.”
23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlledsubstances to patients without resolving numerous red flags of diversion.
On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlledsubstances. While this decision was pending, Morris & Dickson remained an authorized DEA registrant to continue to handle controlledsubstances.
Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal ControlledSubstances Act (“CSA”) to schedule III.
Accounting for controlledsubstances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlledsubstance operations.
Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal ControlledSubstances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C.
Houck — Drugs and substances classified within schedule I of the federal ControlledSubstances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. §
Houck — In addition to regulating drugs of abuse, the federal ControlledSubstances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlledsubstances. By Larry K.
In light of the urgent public health need to facilitate and expedite access to naloxone, FDA is implementing this Guidance immediately without prior public comment. Naloxone is a prescription drug, but unlike some other prescription drugs used in the treatment of opioid addiction such as buprenorphine , it is not a controlledsubstance.
Houck — Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August.
Mr. Houck’s session will address pharmacists’ corresponding responsibility to identify and resolve controlledsubstance prescribing red flags and how to prepare for and manage DEA inspections. The session will occur Friday, March 24th. Pharmacists can earn 1 continuing practice education credit for attending this session.
Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the ControlledSubstances Act (“CSA”). 16, 2023 ( DOJ Press Release ).
Attorney’s Offices, and, importantly for readers of this blog, the Civil Division’s Consumer Protection Branch (CPB), will all consistently reward corporations that voluntarily disclose and remediate misconduct. Our colleague John Fleder has long advocated for a voluntary disclosure program at FDA. And, FDA still doesn’t.
Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. 156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period.
Accounting for controlledsubstances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlledsubstance operations.
Hyman, Phelps & McNamara (HPM) marks its 45thAnniversary year by welcoming three accomplished professionals who reinforce the depth and breadth of the firms FDA and DEA practices. Andrew Hull rejoins the firm as a Director after 6 years as an Assistant United States Attorney in the Western District of Michigan.
Karst — If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. Patent and Trademark Office (“PTO”) for U.S. which brings us to the topic of this post. Patent Nos.
Hull Last month, we blogged on the Department of Justices (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were unconstitutional and that DOJ would no longer defend those removal restrictions in court. By Andrew J.
Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. Niche practices in new drug development, controlledsubstances, advertising, and health care law complement our core FDA practice.
Given the significant growth and development opportunities available in Puerto Rico, Karla and Dara will discuss the FDA’s prescription drug approval process, and more importantly the “exportation” of prescription pharmaceuticals — including controlledsubstances — from Puerto Rico into the United States.
The NPRM seeks to reschedule marijuana from schedule I of the federal ControlledSubstances Act (CSA) to schedule III. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing.
Some of the services HP&M offers include: comprehensive regulatory assessments pre-launch licensing support license gap analysis support for new product/company acquisitions, regulatory diligences DEA registrations and state-controlledsubstance licenses With the complexities of licensure, Sara M. Palmer , Larry K.
Houck — Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlledsubstances with currently accepted medical uses in the U.S. By Larry K. Other anabolic steroids are approved only for use in veterinary medicine.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content