The FDA Law Blog

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance 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 Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.

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The FDA Law Blog

FEBRUARY 27, 2023

Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. DEA’s proposed rule when finalized would authorize telemedicine pursuant to the Controlled Substances Act, 21 U.S.C. § By Karla L.

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Controlled Substances FDA Documentation Labelling 59

European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. FDA’s draft guidance refers to psychedelics as “classic psychedelics”. These should be submitted latest 23 Aug 2023 to be considered.

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The FDA Law Blog

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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The FDA Law Blog

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. By Larry K. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §

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FDA Controlled Substances Chemotherapy Compounding 69

The FDA Law Blog

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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Controlled Substances Hospitals 45

The FDA Law Blog

JULY 31, 2023

CARA amended the Controlled Substances 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).

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Controlled Substances Long-Term Care Facilities Dosage Communication 98

The FDA Law Blog

OCTOBER 9, 2022

We also note there are states where marijuana remains the equivalent of a schedule I controlled substance. Separate and apart from the loosening of marijuana restrictions by these states, marijuana remains a schedule I controlled substance under federal law.

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Controlled Substances 105

The FDA Law Blog

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

The FDA Law Blog

AUGUST 26, 2024

Interested persons,” that is “any person adversely affected or aggrieved by any rule or proposed rule issuable” under the Controlled Substances Act wishing to participate in the hearing must file a written notice of their intention to participate, which DEA will review.

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Controlled Substances 104

The FDA Law Blog

JUNE 10, 2024

Houck — It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. DOJ, Iowa Surgical Center Agrees to Pay $125,000 to Resolve Allegations It Violated the Controlled Substances Act ( June 4, 2024 ). By Larry K.

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The FDA Law Blog

MARCH 12, 2023

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 controlled substances and non-controlled drugs.

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Controlled Substances FDA 98

The Checkup by Singlecare

MARCH 22, 2023

We have a regulator called Health Canada, similar to the Food and Drug Administration (FDA), which works to ensure the safety of our drugs,” Tadrous says. The FDA allows customers to purchase drugs from Canadian online pharmacies and have them shipped to the U.S. If you don’t live near the border between the U.S. Are not licensed.

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Health and Personal Care Stores Controlled Substances Dosage FDA 105

The FDA Law Blog

NOVEMBER 10, 2022

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 controlled substances.” Company Pays $158,760 to Resolve Claims Related to Controlled Substance Thefts From Pharmacies During Inventory, U.S.

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Controlled Substances 59

The Checkup by Singlecare

FEBRUARY 6, 2023

Ambien and Ambien CR are controlled substances , so they have the potential for substance abuse and dependence. Prescribers will consider past drug use or alcohol use and the potential for abuse and dependence before prescribing a controlled substance. It is a controlled substance.

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The FDA Law Blog

AUGUST 8, 2024

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 Controlled Substances Act (“CSA”), to leave marijuana in schedule I, or to deschedule altogether. 21 U.S.C. § 812(c)(c)(10). 21 U.S.C. §

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Controlled Substances Dosage FDA 59

Drug Store News

SEPTEMBER 1, 2023

Lisdexamfetamine Dimesylate capsules are a federally controlled substance used to treat Attention-Deficit/Hyperactivity Disorder and other indications.

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Controlled Substances FDA 52

The FDA Law Blog

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. 73,044 (Oct. DEA’s notice of updates with the Special Surveillance List is attached here.

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Controlled Substances 59

OctariusRx

DECEMBER 12, 2022

Food and Drug Administration (FDA) , U.S. million dollars for violating provisions of the controlled substances act. Do you know what provisions of the controlled substances act apply to your facility? Who in your facility is expert in all aspects of managing controlled substances? Do you have $4.3

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Controlled Substances Hospitals FDA 79

pharmaphorum

SEPTEMBER 3, 2020

The FDA approved Spravato last year but after a troubled clinical development with mixed results from clinical trials and question marks over side effects, with increased risks for dissociation, abuse and suicidality observed. This could lead to rapid and sustained positive mood effects, the company claimed.

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Controlled Substances FDA 116

The FDA Law Blog

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.

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Controlled Substances FDA 64

The FDA Law Blog

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

The FDA Law Blog

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

The FDA Law Blog

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. 72,694, 72,703 (Dec.

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Controlled Substances Documentation Insurance Dosage 52

The Checkup by Singlecare

MARCH 21, 2024

In fact, because it has a risk of abuse and dependence and works similarly to amphetamine drugs, it’s classified as a Schedule IV controlled substance and is available by prescription only. Controlled substances have restrictions on how they’re prescribed and dispensed at pharmacies.

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The FDA Law Blog

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. 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.

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FDA Controlled Substances 59

The FDA Law Blog

JUNE 10, 2024

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 Controlled Substances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C.

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Controlled Substances 59

The FDA Law Blog

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

The FDA Law Blog

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

The Checkup by Singlecare

MAY 1, 2024

It is a Drug Enforcement Administration (DEA) controlled substance in the Schedule II category. Non-amphetamine-based ADHD treatments, such as Strattera , are not controlled substances. Food and Drug Administration (FDA) in 2007 for treatment and symptom control in ADHD.

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Dosage Controlled Substances Labelling Insurance 92

pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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pharmaphorum

OCTOBER 14, 2020

It is the only FDA-approved drug to treat cataplexy associated with narcolepsy not scheduled as a controlled substance by the US Drug Enforcement Administration. Last year, the FDA rejected Wakix for the additional use. Effects can be severe and cause knee buckling or the body to collapse.

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Labelling Controlled Substances FDA 64

The Checkup by Singlecare

OCTOBER 4, 2023

That’s why you may have seen people talk about a medication called Vyvanse, which is FDA approved to treat ADHD and binge eating disorder, as a good option for weight loss. In 2015, the FDA approved Vyvanse to be used in the treatment of binge eating disorder. Does Vyvanse cause weight loss?

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Labelling FDA Controlled Substances Hospitals 125

The FDA Law Blog

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. at 30,039 (emphasis added).

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Controlled Substances Communication 52

The FDA Law Blog

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

The FDA Law Blog

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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The FDA Law Blog

OCTOBER 12, 2022

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 controlled substance.

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