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 ).

Controlled Substances

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.

FDA

The FDA Law Blog

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. § Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter. which brings us to the topic of this post. Patent Nos.

Labelling

The Checkup by Singlecare

OCTOBER 9, 2024

Food and Drug Administration (FDA) does not approve clonidine as a sleep aid. “It It is not approved in adults directly as a sleep aid, but it is often used ‘off-label’ as a non-controlled substance that aids in sleep,” explains Dr. Sulagna Misra, MD, BCMAS, founder of Misra Wellness. How much clonidine should I take for sleep?

Controlled Substances

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.,

FDA

The FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. This means that there multiple same-day FDA NDA approvals for the same drug. FDA-2020-E-1840 (Mar.

FDA

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).

Controlled Substances

Pharmaceutical Technology

SEPTEMBER 23, 2022

And, because it also manufactures products, its staff is current on regulatory requirements and FDA/ICH Guidance documents. Since CDMOs have different material handling capabilities, when choosing a partner, it’s important to understand if the drug will involve a controlled substance, hormone, small molecule or biological.

Packaging

The FDA Law Blog

FEBRUARY 27, 2023

4:2022-cv-02396 S.D. 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. The DEA has even made the same mistake. 73246 (Nov. Aims Institute, PLLC, v. Merrick Garland, et. al , Case No.

Documentation

The FDA Law Blog

OCTOBER 19, 2022

If you need more motivation to clean out your cluttered medicine cabinet, the Drug Enforcement Administration (“DEA”) and its law enforcement partners are hosting thousands of local drop-off locations nationwide for proper disposal of unneeded medication on Saturday, October 29, 2022, from 10 am to 2 pm local time.

Controlled Substances

The Checkup by Singlecare

AUGUST 5, 2023

Initially approved by the FDA in 1996 for ADHD, Adderall has since become a widely prescribed medication in the United States. As there is currently a drug shortages of Adderall in the United States, which has been ongoing since October of 2022, more healthcare providers may prescribe the generic alternative.

Dosage

The Checkup by Singlecare

AUGUST 21, 2024

Belsomra was the first DORA, approved by the Food and Drug Administration (FDA) in 2014. Quviviq is a newer drug, with its first approval in 2022. Quviviq and Belsomra are Schedule IV controlled substances. Belsomra is manufactured by Merck Sharp & Dohme and contains suvorexant.

Insurance

The Checkup by Singlecare

OCTOBER 29, 2024

These medications differ in FDA-approved uses, how they work, dosage forms, and potential side effects. Mounjaro is a brand-name drug approved in 2022 that contains the active ingredient tirzepatide. Mounjaro is a newer drug FDA-approved to treat Type 2 diabetes. As a result, it directly helps promote weight loss.

Dosage

The Checkup by Singlecare

NOVEMBER 14, 2022

Food and Drug Administration (FDA) in 1959, is available as an oral tablet and capsule. It is a Schedule IV controlled substance. All of the weight loss drugs listed are FDA-approved prescription medications. Contrave has a black box warning , the strongest warning required by the FDA.

Labelling

The FDA Law Blog

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). DEA alleged that UMHS failed to maintain complete and accurate records and failed to timely notify DEA of controlled substance thefts.

Controlled Substances

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.;

Controlled Substances

The FDA Law Blog

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. Whether the drug is an immediate precursor of a substance already controlled.

Controlled Substances

Pharmaceutical Technology

MAY 9, 2023

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet.

Controlled Substances

The FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. 2022 Guideline”). 2022 Guideline at 15. (We An important part of the 2022 Guideline includes CDC’s pronouncement that some laws, regulations and policies have misapplied the 2016 guidelines and likely contributed to patient harm.

Patient Care

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.

Mayo Clinic

The FDA Law Blog

JANUARY 8, 2023

See President Biden Gives the Green Light for Significant Marijuana Reform, October 10, 2022. It is unclear whether DEA, FDA or both will make the determination whether a shortage exists. Commercial Production and Distribution of FDA-Approved Cannabis Drugs. Earl Blumenauer, Press Release, Dec. Federal Research. 21 U.S.C. §

Controlled Substances

The Checkup by Singlecare

DECEMBER 10, 2024

Trazodone is a prescription medication approved by the Food and Drug Administration (FDA) to treat depression , a common mental health condition. Healthcare providers may prescribe both clonazepam and trazodone for insomnia even though theyre FDA approved for use as sleep aids. Klonopin is the brand name for clonazepam.

Labelling

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.

FDA

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.

FDA

The FDA Law Blog

DECEMBER 21, 2023

In October 2022 President Joseph Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing expeditiously how cannabis is scheduled under federal law. By Hyman, Phelps & McNamara, P.C. — Hyman, Phelps & McNamara, P.C.,

Controlled Substances

The Checkup by Singlecare

OCTOBER 15, 2024

Since its FDA approval in 1993, gabapentin has been one of the most commonly prescribed epilepsy medications—but that’s not its only use. Gabapentin’s pain management powers have made it a popular drug for controlling postoperative pain. This is important because opioid addiction is an epidemic in the U.S.

Dosage

The Checkup by Singlecare

DECEMBER 10, 2024

Methocarbamol , the generic form of Robaxin , is a centrally acting muscle relaxant available as an oral tablet approved by the Food and Drug Administration (FDA) for short-term relief of acute muscle pain caused by sprains, strains, and other musculoskeletal conditions in people ages 16 and older. What is methocarbamol?

Labelling

PQA

SEPTEMBER 9, 2022

The 2022 PQA Headlines and Highlights details our accomplishments together. The kiosks accept prescription and over-the-counter medications for both humans and pets, including controlled substances. We look forward to the collaborations ahead as we celebrate the achievements of 2022.

Community Pharmacies

The FDA Law Blog

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. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K. 44,597 (May 21, 2024). 29, 2023) (“Basis”); NPRM at 44,603.

Controlled Substances

The FDA Law Blog

FEBRUARY 11, 2024

FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. July 6, 2022). In other words, no rescheduling. There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. Letter to President Joseph Biden, et al.

Controlled Substances

The FDA Law Blog

APRIL 29, 2024

Later Democratic lawmakers, eleven senators and ten members of Congress, also penned a letter to Administrator Milgram and Attorney General Merrick Garland imploring DEA to not only “promptly remove marijuana” from schedule I of the Controlled Substances Act (“CSA”), but to deschedule it altogether. April 24, 2024.

Controlled Substances

The FDA Law Blog

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” As explained more fully explained below, that impression would be partially correct, but partially incorrect. Riley Griffin et al.,

Controlled Substances

The Checkup by Singlecare

DECEMBER 1, 2023

Common side effects of Plan B According to a review of 11 studies of emergency contraception , menstrual changes are the most common side effect of using emergency birth control pills like Plan B. In fact, women who miss at least three doses of daily birth control pills are advised to use emergency contraception after having unprotected sex.

FDA

The FDA Law Blog

APRIL 6, 2025

Hyman, Phelps & McNamara (HPM) marks its 45thAnniversary year by welcoming three accomplished professionals who reinforce the depth and breadth of the firms FDA and DEA practices. Julie Kims 2022 law school graduation year belies her experience. Julie Kim joins the firm as an Associate.

Controlled Substances

The Checkup by Singlecare

JULY 2, 2025

Note: Since Vyvanse is a stimulant and a controlled substance (like Adderall), some plans may also have quantity limits , which are restrictions on the amount you can get per month. Reason for taking it The FDA has approved Vyvanse for ADHD and binge eating disorder. depression or narcolepsy), it’s considered an off-label use.

Insurance Coverage

The Thyroid Pharmacist

NOVEMBER 15, 2024

17] Ozempic is a once-weekly injection that was approved by the FDA in 2017 for use in adults with type 2 diabetes. 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”).

Immunization