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.

Controlled Substances

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. §

Controlled Substances

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.

Controlled Substances

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US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. FDA’s draft guidance refers to psychedelics as “classic psychedelics”.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.

FDA

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).

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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. §

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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?

Labelling

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. §

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

Dosage

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.

Controlled Substances

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.

Controlled Substances

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

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.

Controlled Substances

The FDA Law Blog

APRIL 22, 2024

Houck — Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August.

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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

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

FDA

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 an opioid pain medication that’s FDA-approved to treat moderate-to- severe pain that isn’t managed by other treatments.

Dosage

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.

Documentation

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. §

Dosage

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.

Controlled Substances

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.

Dosage

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.

Nursing Homes

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.

FDA

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.

Controlled Substances

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.

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. 29, 2023). Letter to U.S. Letter to President Joseph R. 21 U.S.C. §

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

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. §

Controlled Substances