OctariusRx

APRIL 17, 2023

April 22, 2023, is DEA National Prescription Drug Takeback Day and at OctariusRx, we recognize and support the DEA’s efforts to provide education on the potential for abuse of medications. The post April 22, 2023 is DEA National Prescription Drug Takeback Day appeared first on OctariusRX. Contact us for assistance.

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Controlled Substances 90

OctariusRx

AUGUST 28, 2023

The 2023 version of the OctariusRx medication safety quiz is about to be released. What does the Medication Safety Quiz 2023 cover and how do you get one? The quiz focuses on some of the most commonly encountered situations, including allergies, labeling medications and controlled substances. Contact us for assistance.

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OctariusRx

NOVEMBER 20, 2023

The 2023 version of the OctariusRx USP 800 assessment quiz is about to be released! With the enforcement of USP Chapter 800 beginning on November 1, 2023, facilities will be required to assess staff competency on an annual basis. The post The 2023 USP 800 Assessment Quiz appeared first on OctariusRX. Contact us for assistance.

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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. That emergency declaration is set to expire on May 11, 2023. By Karla L. 21 U.S.C. §

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Drug Store News

SEPTEMBER 30, 2022

Comments to the Centers for Medicare & Medicaid Services call for enforcement of electronic prescribing of controlled substances requirements no later than Jan.

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Controlled Substances 98

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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The FDA Law Blog

MARCH 12, 2023

When the public health emergency ends on May 11, 2023 , so do these exemptions. 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

OctariusRx

NOVEMBER 13, 2024

With the enforcement of USP Chapter 800 beginning last year on November 1, 2023, facilities will be required to assess staff competency on an annual basis. Earlier this year, we discussed Nursing Medication Calculations, Medication safety and Controlled Substances to help your staff hone their skills and let you assess their abilities.

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Controlled Substances 99

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. 30,038 (May 10, 2023). 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

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.

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Controlled Substances 59

The FDA Law Blog

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. comments on the two proposed rules.

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Controlled Substances 64

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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The Checkup by Singlecare

DECEMBER 7, 2023

Here are the 5 top health and wellness posts of 2023, based on what pharmacy professionals read most. What pharmacists should know about the blockbuster drugs of 2023 Blockbuster drugs are medications that generate significant annual revenue ($1 billion or more) for pharmaceutical companies. Read more here.

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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. Designation of 4-Piperidone as a List I Chemical, 88 Fed. a)(38) (Apr.

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Controlled Substances 59

The FDA Law Blog

FEBRUARY 19, 2023

Mr. Houck’s session will address pharmacists’ corresponding responsibility to identify and resolve controlled substance 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.

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The FDA Law Blog

MAY 7, 2023

Palmer — On May 3, 2023, DEA’s Administrator Anne Milgram issued a very brief and lightly publicized statement announcing that DEA intends to issue a “temporary rule” extending telemedicine flexibilities that existed during the COVID-19 Emergency Declaration, which Declaration is set to expire on May 11, 2023. By Karla L.

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Controlled Substances 52

European Pharmaceutical Review

JUNE 26, 2023

For example, regarding psychedelics that are currently Schedule I controlled substances, the draft guidance noted that activities associated with investigations under an Investigational New Drug (IND) application must comply with applicable Drug Enforcement Administration regulatory requirements.

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FDA Controlled Substances 98

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.” Last December we blogged on the $275,000 civil penalty imposed by the U.S. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

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The FDA Law Blog

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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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

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

The FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. is the largest dedicated food and drug law firm in the country.

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Controlled Substances FDA 40

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. Vyvanse was initially approved by the U.S.

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The Happy PharmD

OCTOBER 11, 2024

Despite its substantial revenue of $24 billion in 2023, Rite Aid faced a steady decline leading to its eventual bankruptcy filing. Allegations of improper handling of controlled substances and subsequent legal battles resulted in significant penalties and loss of trust from vendors and customers alike.

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The FDA Law Blog

MARCH 27, 2023

Thank you to those who registered for and attended Hyman, Phelps & McNamara’s March 23, 2023 lunchtime webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.” As promised during the 90-minute program, we provide our slides here, and a recording of the program, here (passcode.

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Controlled Substances 40

The FDA Law Blog

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Democratic senators also weighed in, supporting rescheduling to schedule III in December 2023. treaty obligations under the Single Convention on Narcotic Drugs, 1961.

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Controlled Substances FDA 59

The Checkup by Singlecare

OCTOBER 4, 2023

“These effects are more likely if you have a history of mental illness, substance [use disorder], or bipolar disorder.” Vyvanse dependence and addiction Vyvanse is a Schedule II controlled substance , according to the FDA. Access FDA Eating & Physical Activity to Lose or Maintain Weight. appeared first on The Checkup.

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Labelling FDA Controlled Substances Hospitals 125

The FDA Law Blog

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. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed. By Larry K. 50,036 (Aug.

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Controlled Substances Labelling 52

The Checkup by Singlecare

MARCH 23, 2023

The United States Congress legalized CBD derived from hemp in 2018 when the Agricultural Improvement Act was signed into law, removing hemp from the Federal Controlled Substances Act. However, at the federal level, marijuana is still classified as a Schedule I controlled substance by the Drug Enforcement Agency (DEA).

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ISPE

MARCH 8, 2023

Introducing CoP Leader Profiles: Rachel Owen Trudy Patterson Wed, 03/08/2023 - 09:46 InTouch March / April 2023 Introducing CoP Leader Profiles: Rachel Owen Marcy Sanford 1 March 2023 With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders.

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Controlled Substances 52

The FDA Law Blog

JULY 1, 2024

The request for hearing follows a n October 2023 letter preceding the NPRM from six former Administrators and five former Directors of National Drug Policy. The C ontrolled S ubstances A ct (“CSA”) requires analysis of eight statutory factors for scheduling, rescheduling, or descheduling substances of abuse. 21 U.S.C. §

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The Checkup by Singlecare

NOVEMBER 5, 2024

Often referred to by its brand name Ultram , tramadol is an opioid medication that’s classified as a schedule IV controlled substance due to its potential for physical dependence , abuse, and addiction. Tramadol is a generic prescription medication that’s used to relieve moderate-to- severe pain that’s unmanaged by other treatments.

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The Checkup by Singlecare

JANUARY 15, 2025

Opioid analgesics , which work via the central nervous system ( CNS ), are a class IV controlled substance, meaning they have a high likelihood of misuse or abuse. A 2023 system review looked at pain from tooth extractions in adults. Other opioids include hydrocodone and oxycodone.

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The FDA Law Blog

AUGUST 16, 2023

And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.

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The FDA Law Blog

OCTOBER 19, 2023

local time on Saturday, October 28, 2023. DEA is not a band, but along with its law enforcement partners, the agency will host thousands of local drop-off locations nationwide for clearing out and proper disposal of expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 p.m.

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Controlled Substances 40

The FDA Law Blog

FEBRUARY 27, 2023

In a case involving a challenge to a Freedom of Information Request (“FOIA”) submitted to DEA, the DOJ and DEA appear to now argue that DEA is a “component” of the DOJ and not an agency. Aims Institute, PLLC, v. Merrick Garland, et. al , Case No. 4:2022-cv-02396 S.D.

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Documentation Controlled Substances FDA 45

The Checkup by Singlecare

JANUARY 12, 2024

Other considerations While taking tramadol, it can also be helpful to be aware of the following precautions: Dependence and addiction : Tramadol is a controlled substance with a potential risk for dependence or abuse, and its misuse may lead to addiction.

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