The FDA Law Blog

MARCH 12, 2023

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. When the public health emergency ends on May 11, 2023 , so do these exemptions. By almost all accounts, these exemptions also improved prescribing and dispensing of medication to patients that need them.

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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. 39,479 (June 16, 2023). 73,044 (Oct. 21 U.S.C. § 21 U.S.C. § 21 U.S.C. §

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Controlled Substances 59

The FDA Law Blog

DECEMBER 4, 2023

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 controlled substances. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

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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 Checkup by Singlecare

DECEMBER 7, 2023

Here are the 5 top health and wellness posts of 2023, based on what pharmacy professionals read most. But because they’re dietary supplements, they’re not regulated by the FDA. In case you missed them, here are eight blockbuster drugs from 2023, plus their indications and benefits. Read more here. Read more here. Read more here.

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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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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

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

Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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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

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

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

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 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 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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The FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.

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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 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 Checkup by Singlecare

MAY 5, 2024

It’s a Schedule II controlled substance that’s approved by the U.S. Food and Drug Administration (FDA) to treat ADHD. Like Focalin, Vyvanse is also a Schedule II controlled substance approved by the FDA to treat ADHD. As of 2023 , there are generic versions of Vyvanse available. | What is Vyvanse?

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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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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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The Checkup by Singlecare

OCTOBER 25, 2023

Meloxicam is not a controlled substance. It is not considered addictive in the same way as substances like opioids or certain recreational drugs. You can take meloxicam in the morning or night, depending on what works best for your schedule. What happens if you take meloxicam every day? UCLA Health (2018) Mobic label , U.S.

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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.

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The FDA Law Blog

FEBRUARY 27, 2023

In many cases, it appears DEA does not have the resources or infrastructure to maintain and produce the information to respond to FOIA requests as do other administrative agencies such as FDA. 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 FDA Law Blog

APRIL 13, 2023

The Drug Enforcement Administration (“DEA”) could voice a modern variation, “Bring out your meds,” as the agency and its law enforcement partners host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, April 22, 2023, from 10:00 a.m. to 2:00 p.m. local time.

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Controlled Substances 59

The Checkup by Singlecare

DECEMBER 12, 2023

The Food and Drug Administration (FDA) even sent a special communication to call attention to this risk. The Drug Enforcement Administration (DEA) categorizes zolpidem as a controlled substance, meaning that it has significant potential for abuse. For that reason, it is typically best to avoid combining opiates with zolpidem.

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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 Checkup by Singlecare

JANUARY 12, 2024

Key takeaways | Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Tramadol, commonly known by the brand names Ultram and ConZip, is approved by the Food and Drug Administration (FDA) to treat moderate to severe pain.

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The Checkup by Singlecare

NOVEMBER 30, 2023

New York state has one of the largest populations covered by Medicaid programs, with nearly 9 million people receiving benefits as of 2023. Prescription drug coverage Under the New York State Medicaid Pharmacy program (NYRx), FDA-approved and medically necessary drugs are eligible for coverage.

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The Checkup by Singlecare

JANUARY 15, 2024

Food and Drug Administration (FDA) as a treatment for narcolepsy. SSRIs are the most commonly prescribed type of antidepressant —and they are approved by the FDA for this purpose. Drescher notes that not every healthcare professional will feel comfortable prescribing certain controlled substances to patients with depression.

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The FDA Law Blog

AUGUST 16, 2023

The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ). Therefore, the presentation of these claims (i.e., What does this mean

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The FDA Law Blog

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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The Checkup by Singlecare

DECEMBER 26, 2023

Safety measures while using testosterone What are the FDA warnings about testosterone? The Food and Drug Administration (FDA) has multiple boxed warnings for testosterone therapy. The FDA has classified testosterone drugs as Schedule III controlled substances because of their potential for abuse and dependency.

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The Checkup by Singlecare

MAY 8, 2023

Tramadol has been available in the United States since 1995, but not until 2014 did it become a schedule IV controlled substance by the Food and Drug Administration (FDA) based on data suggesting abuse potential similar to other schedule IV opioids available at that time. What can I take in place of tramadol?

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The FDA Law Blog

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.;

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