FDA Law Blog: Biosimilars

MAY 10, 2023

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. effective May 12, 2023 through November 11, 2024, Telemedicine relationships that are included in this period must be “in effect” as of November 11, 2023. By Karla L.

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Controlled Substances Communication 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA.

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

National Association of Boards of Pharmacy

FEBRUARY 5, 2024

The National Association of State Controlled Substances Authorities (NASCSA) has partnered with Talem Health to create a one-hour, on-demand continuing education (CE) activity for pharmacists and pharmacy technicians to improve prescription monitoring program (PMP) data.

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Data Entry Pharmacy Technician Controlled Substances 52

National Association of Boards of Pharmacy

JANUARY 31, 2024

provided prescribers with the option to use e-prescriptions for controlled substances (CS) based on an interim final rule published in 2010. This blog was adapted from an article that originally appeared in the January 2024 issue of Innovations. Aiming to prevent these errors, Drug Enforcement Administration.

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Prescription Filling Controlled Substances 85

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. 4, 2024), at 1. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing. Prehearing Ruling (Dec.

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Controlled Substances Documentation 52

LifeProNow

MARCH 10, 2023

billion as part of the president’s fiscal year (FY) 2024 budget. The FY 2024 request, which covers the period from Oct. 30, 2024, includes new efforts for high priority program areas. March 09, 2023: “The U.S. Food and Drug Administration announced it is requesting $7.2 1, 2023, through Sept.

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Labelling Packaging Controlled Substances 130

Integra X Files

FEBRUARY 20, 2023

Beginning in 2024, the administration fee for COVID-19 immunizations will be in line with other Medicare Part B vaccines. The ability to prescribe controlled substances without an in-person consultation will end with the expiration of the PHE.

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Nursing Homes Vaccines Controlled Substances Hospitals 89

FDA Law Blog: Biosimilars

JULY 1, 2024

Karst — The Drug Enforcement Administration (“DEA”) has received more than 2 7 ,000 public comments in response to its May 21, 2024 , Notice of Proposed Rulemaking (“ NPRM ”) to reschedule marijuana from schedule I to schedule III. Letter to DEA Administrator Anne Milgram, from Peter Bensinger, et al., ( June 19, 2024 ).

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Dosage Controlled Substances 52

FDA Law Blog: Biosimilars

APRIL 17, 2024

DEA, with its law enforcement partners, will host thousands of local drop-off locations nationwide for clearing out and proper disposal of unwanted expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 pm local time on Saturday, April 27, 2024. Events over the years have led to the removal of more than 17.9

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Controlled Substances 59

FDA Law Blog: Biosimilars

JANUARY 24, 2024

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.

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Controlled Substances 59

FDA Law Blog: Biosimilars

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § 112-029 ), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.” Patent Nos.

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Labelling Controlled Substances 59

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

On February 8, 2024—the same day the PTO requested information with respect to the multiple PTE applications for idelalisib—the FDA sent a letter to the PTO in response to the PTE applications for for U.S. Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. Patent Nos. 7,214,695 and 7,214,696.

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Controlled Substances Hospitals 59

FDA Law Blog: Biosimilars

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). By Larry K.

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Controlled Substances Chemotherapy Dosage Labelling 69

FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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Inpatient Hospitals Dosage Controlled Substances 59

FDA Law Blog: Biosimilars

DECEMBER 21, 2023

Director Larry Houck will present a webinar on HHS’ cannabis rescheduling recommendation hosted by the National Association of State Controlled Substance Authorities (“NASCSA”) scheduled for Tuesday, January 9, 2024 at 3:00 pm (Eastern). Hyman, Phelps & McNamara, P.C.,

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Controlled Substances 52

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen.

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Controlled Substances Labelling 52

FDA Law Blog: Biosimilars

NOVEMBER 26, 2024

Houck — Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed.

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Controlled Substances 75

FDA Law Blog: Biosimilars

MARCH 24, 2025

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K.

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Controlled Substances Labelling 64

FDA Law Blog: Biosimilars

OCTOBER 20, 2024

Unwanted and expired controlled prescription medication languishing in medicine cabinets are susceptible to theft, misuse and abuse. DEA and its law enforcement partners will once again host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, October 26, 2024, from 10:00 a.m. to 2:00 p.m.

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Controlled Substances 59

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. By Karla L. The federal telemedicine flexibilities (i.e., The federal telemedicine flexibilities (i.e.,

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Controlled Substances 52

The Thyroid Pharmacist

NOVEMBER 15, 2024

I also prefer semaglutide drugs over other weight loss drugs out there (for example, phentermine, a controlled substance that can be habit forming, or orlistat, a drug that results in fat malabsorption and “disaster pants”). June 25, 2024. Accessed November 13, 2024 [link] [20] Tirrell M. Epub 2018 May 14. In: StatPearls.

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Diabetes Immunity Immunization Compounding 75

FDA Law Blog: Biosimilars

MARCH 6, 2025

109 (2024), the Supreme Court upheld a decision by the U.S. (For an in-depth review of the history of ALJs and the removal protections enacted by the APA, see Brief of Amicus Curiae Federal Administrative Law Judges Conference 8-20, SEC v. Jarkesy , No. 22-859 (Sept. The constitutionality of ALJs has been a hot legal topic of late.

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Controlled Substances 105

FDA Law Blog: Biosimilars

APRIL 22, 2024

Milgram’s predecessors, and Directors of National Drug Policy urging not to reschedule; the January 2004 letter Democratic state attorneys general pushing for rescheduling to schedule III; and the January 2024 letter from Democratic senators requesting descheduling altogether. The senators write that the U.S.

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Controlled Substances 59

FDA Law Blog: Biosimilars

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. treaty obligations in rescheduling. 21 U.S.C. § 812(b)(1).

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Controlled Substances Chemotherapy Dosage Labelling 95

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Letter 3: Top Ten Reasons for Descheduling Cannabis Altogether From: Democratic Senators Date: January 29, 2024 Twelve Democratic senators signed Letter 3. January 29, 2024). Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.

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Controlled Substances Chemotherapy Compounding 59

FDA Law Blog: Biosimilars

APRIL 29, 2024

Houck — On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. April 24, 2024. Vice president criticizes federal cannabis restrictions during White House weed event , March 15, 2024.)

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Controlled Substances 59