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. part 1306 (which include DEA’s general requirements for prescribing controlled substances); 88 Fed. By Karla L. 1307.41and 42 C.F.R.

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Controlled Substances Communication 52

FDA Law Blog: Biosimilars

MAY 7, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing controlled substances 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.”

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Controlled Substances 52

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. 21 U.S.C. §

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Controlled Substances Documentation 116

FDA Law Blog: Biosimilars

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 21 U.S.C. §

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Controlled Substances 53

FDA Law Blog: Biosimilars

MAY 3, 2023

Accounting for controlled substances, 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 controlled substance operations.

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Controlled Substances 52

FDA Law Blog: Biosimilars

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency.

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Controlled Substances 64

FDA Law Blog: Biosimilars

MARCH 30, 2023

Houck — Perhaps you obtain controlled substance quotas or submit ARCOS reports? DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical requirements in Houston on May 2-4, 2023. By Larry K.

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Controlled Substances 59

FDA Law Blog: Biosimilars

MAY 31, 2023

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 controlled substances. While this decision was pending, Morris & Dickson remained an authorized DEA registrant to continue to handle controlled substances.

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Controlled Substances 59

FDA Law Blog: Biosimilars

MAY 22, 2023

Accounting for controlled substances, 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 controlled substance operations.

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Controlled Substances 40

FDA Law Blog: Biosimilars

AUGUST 21, 2023

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 Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ).

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Controlled Substances General Merchandise Stores Grocery Stores Compounding 52

FDA Law Blog: Biosimilars

APRIL 18, 2023

Houck — In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances. By Larry K.

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Controlled Substances 59

Board Vitals - Pharmacist

JANUARY 9, 2021

Alabama – 2 Credits The Alabama State Board of Medical Examiners requires 2 credit hours every 2 years on controlled substances for physicians. Stay tuned, we’ll update this blog and our Opioid CME offerings as we get more information on new state requirements. Colorado No opioid CME requirements.

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Controlled Substances 52

National Association of Boards of Pharmacy

DECEMBER 6, 2023

Furthermore, xylazine is also associated with physical dependence, withdrawal symptoms, and a general substance use disorder (SUD). While federal law does not classify the drug as a controlled substance (CS), some states have enacted laws or temporary orders to regulate its possession, distribution, and use.

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Controlled Substances Packaging 72

FDA Law Blog: Biosimilars

MARCH 10, 2024

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 Controlled Substances Act (“CSA”) to schedule III.

Controlled Substances 64

Controlled Substances 64

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

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-controlled substance licenses With the complexities of licensure, Sara M. Palmer , Larry K.

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Controlled Substances Documentation Pharmaceutical Manufacturing Communication 45

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances 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. §

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Controlled Substances 59

Digital Pharmacist

AUGUST 12, 2022

In today’s blog, we’re going to provide you with a few tips. . Pharmacies should prepare for higher volumes of controlled substance prescriptions used to treat ADHD like amphetamine salts, dextroamphetamine, lisdexamfetamine, methylphenidate, and dexmethylphenidate.

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Controlled Substances Immunity Immunization Vaccines 90

FDA Law Blog: Biosimilars

MARCH 12, 2023

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 controlled substances and non-controlled drugs.

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Controlled Substances 98

National Association of Boards of Pharmacy

JULY 12, 2023

During multiple pharmacy investigations, I discovered that pharmacists were diverting controlled substances for their personal use. This blog was adapted from an article that originally appeared in the May 2023 issue of Innovations. Is there an inspection experience that you found particularly interesting, egregious, or unusual?

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Pharmacy Technician Pharmacy Management Controlled Substances Communication 96

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

JANUARY 11, 2024

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 controlled substances — from Puerto Rico into the United States.

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Controlled Substances 59

FDA Law Blog: Biosimilars

JANUARY 24, 2024

FDA Law Blog is a conference media partner. This in-depth training will include practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks! As such, we can offer our readers a special 10% discount.

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Controlled Substances 59

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. “While our attorneys don’t do this work for the recognition, it is gratifying to see their excellent work recognized.

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Controlled Substances Drug Pricing Drug Development 40

FDA Law Blog: Biosimilars

MARCH 27, 2023

As promised during the 90-minute program, we provide our slides here, and a recording of the program, here (passcode. Our attorneys are happy to respond to questions you may have, and look forward to hearing from you.

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Controlled Substances 40

FDA Law Blog: Biosimilars

AUGUST 4, 2023

Houck — Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlled substances with currently accepted medical uses in the U.S. By Larry K. Other anabolic steroids are approved only for use in veterinary medicine.

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Controlled Substances Labelling 52

FDA Law Blog: Biosimilars

MARCH 9, 2023

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. That means that the Criminal Division, 94 U.S. Attorney’s Offices around the country.

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Controlled Substances Documentation 52

Board Vitals - Pharmacist

SEPTEMBER 3, 2022

As of November 2022, NPs have the authority to prescribe medications, including controlled substances, medical devices, and services, medical equipment and supplies in 26 states. The post How to Fulfill Your ANCC Pharmacology Requirement Fast & Easily appeared first on BoardVitals Blog.

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Controlled Substances 52

FDA Law Blog: Biosimilars

APRIL 21, 2024

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.

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Labelling Controlled Substances 59

National Association of Boards of Pharmacy

SEPTEMBER 27, 2023

In this blog, she shares stories from her career and how the NABP accreditation and inspection team works to protect public health. In the role of Compliance Senior Manager, Accreditation and Inspection Programs, Betty Jones tackles complex compliance issues to keep patients safe around the nation.

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Sterile Compounds Controlled Substances Compounding Hospitals 59

FDA Law Blog: Biosimilars

APRIL 8, 2024

Specifically, DEA establishes an aggregate production quota (APQ) for each class of controlled substance listed in schedule I and II, and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, which limits the amount of each substance that can be manufactured in a given year.

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Inpatient Hospitals Dosage Controlled Substances 59

Board Vitals - Pharmacist

JANUARY 6, 2023

Upon first renewal, requirements include one hour in HIV/AIDS, professional and medical ethics, Florida laws and rules, and controlled substances, as well as, two hours of domestic violence and medical errors prevention. Physicians who prescribe controlled substances must earn 3 hours per CME cycle on controlled substance prescribing.

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Controlled Substances Documentation 59

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.

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Controlled Substances Chemotherapy Compounding Dosage 69

FDA Law Blog: Biosimilars

APRIL 17, 2024

By Larry K.

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Controlled Substances 59

FDA Law Blog: Biosimilars

APRIL 13, 2023

By Larry K. Houck — Eric Idle, as a body collector, immortalized the phrase, “Bring out your dead,” in the 1975 comedy classic, Monty Python and the Holy Grail. to 2:00 p.m. local time.

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Controlled Substances 59

The Happy PharmD

APRIL 26, 2023

Dexamethasone oral solution is not a narcotic or controlled substance. These were the problems my girlfriend and I experienced with Dexamethasone oral solution: The pharmacy does not carry Dexamethasone oral solution. This one baffled me. It is not a product that a pharmacy would be scared to have on its shelf (due to theft).

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Dosage Hospitals Pharmacy Technician Prescription Filling 52

FDA Law Blog: Biosimilars

OCTOBER 19, 2023

By Larry K.

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Controlled Substances 40

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