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 52

Controlled Substances General Merchandise Stores Grocery Stores Compounding 52

The FDA Law Blog

JANUARY 11, 2024

This day-long (FREE) seminar is a must-attend event for anyone in the pharmaceutical sector interested in understanding the “ins and outs” of doing business in the Territory, as well as an opportunity to interact with those who already have a keen understanding of doing business in Puerto Rico. HPM is a co-sponsor of the event.

Controlled Substances 59

Controlled Substances 59

The Checkup by Singlecare

DECEMBER 13, 2024

Food and Drug Administration (FDA) for anxiety, but they have long been proven effective in helping some people with anxiety. Its not a controlled substance. These medications, which include Xanax ( alprazolam ), Ativan ( lorazepam ), and Klonopin ( clonazepam ), are controlled substances for a reason.

Controlled Substances 81

Controlled Substances Labelling Dosage FDA 81

The Checkup by Singlecare

NOVEMBER 18, 2024

Adderall ( amphetamine-dextroamphetamine ) and Vyvanse ( lisdexamfetamine dimesylate ) are both brand-name central nervous system (CNS) stimulants approved by the Food and Drug Administration (FDA) for the treatment of ADHD. Adderall is also FDA approved for narcolepsy, and Vyvanse is also FDA approved for binge eating disorder.

FDA 99

FDA Controlled Substances Communication Insurance 99

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 52

Controlled Substances Medical Records Chemotherapy Compounding 52

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 59

FDA Controlled Substances Hospitals 59

The Checkup by Singlecare

JANUARY 19, 2023

This can be a serious concern, especially if the medications are potentially toxic or controlled substances. Patients can drop off medications at permanent collection sites or periodic take back events. At these events, patients can dispose of their medications in a bin or mail them back.

Health and Personal Care Stores 52

Health and Personal Care Stores Controlled Substances Dosage Labelling 52

The FDA Law Blog

APRIL 17, 2024

Events over the years have led to the removal of more than 17.9 DEA, with its law enforcement partners, will host thousands of local drop-off locations nationwide for clearing out and proper disposal of unwanted expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 pm local time on Saturday, April 27, 2024.

Controlled Substances 59

Controlled Substances 59

The Checkup by Singlecare

AUGUST 17, 2024

It’s also a sedative, so it can help dogs feel calmer before or during events that panic or stress them, such as thunderstorms and vet visits. In humans, clonazepam is FDA-approved to treat panic disorder. It’s more suitable when used occasionally to calm the dog before or during fear—or anxiety-inducing events.

Dosage 52

Dosage Controlled Substances Labelling Hospitals 52

DiversifyRx

OCTOBER 26, 2023

If you receive a prescription for a controlled substance like Suboxone, you must have an X-DEA number. Supplements & 510k Devices: Understanding FDA classifications is crucial for PBM billing compliance. Coupon Usage: PBMs may have different rules based on FDA classifications, especially when it comes to using coupons.

Communication 52

Communication Controlled Substances FDA Independent Pharmacies 52

BuzzRx

OCTOBER 14, 2022

This can help to prevent the systemic adverse events associated with a drug. Off-Label Medication Use Sometimes healthcare providers prescribe an FDA-approved medication to treat a condition for which it is not FDA-approved. This might require the dosage to be adjusted. Who regulates compounding pharmacies?

Compounding Pharmacies 52

Compounding Pharmacies Compounding Dosage Sterile Compounds 52

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. These include serious cardiovascular , kidney, and gastrointestinal adverse events.

Dosage 52

Dosage Controlled Substances FDA 52

The FDA Law Blog

OCTOBER 19, 2023

The events have led to the removal of more than 17 million pounds of unwanted medication across the country. local time on Saturday, October 28, 2023. DEA has held Drug Take Back Days each spring and autumn since 2010.

Controlled Substances 40

Controlled Substances 40

The Checkup by Singlecare

AUGUST 21, 2024

Belsomra was the first DORA, approved by the Food and Drug Administration (FDA) in 2014. A network analysis compared the effectiveness of different doses of FDA-approved sleep medications, including suvorexant and daridorexant, by analyzing data from nine clinical trials with 7,257 total participants.

Insurance 52

Insurance Insurance Coverage Controlled Substances FDA 52

The Checkup by Singlecare

JULY 1, 2024

Food and Drug Administration (FDA) to treat osteoarthritis and rheumatoid arthritis. It may lead to fewer severe adverse events compared to diclofenac. Unlike opioids , which are stronger pain relievers, neither diclofenac or meloxicam is classified under the Controlled Substances Act.

Dosage 52

Dosage Insurance Labelling Insurance Coverage 52

The Checkup by Singlecare

JULY 30, 2024

mg/kg single intravenous injection Lorazepam is not FDA-approved for animal use, so pet owners will use human-formulated versions or lorazepam specially formulated by a compounding pharmacy. If lorazepam is being used for stressful situations, give the dose at least one hour before the stress-inducing event. mg, 1 mg, and 2 mg.

Dosage 52

Dosage Hospitals Controlled Substances Compounding Pharmacies 52

BuzzRx

NOVEMBER 11, 2022

Besides the concern for gastrointestinal side effects, NSAIDs also have precautions for cardiovascular events such as heart attacks. In 2020, the FDA switched Voltaren’s status from a prescription-only drug to an OTC product. Neither diclofenac nor meloxicam is a controlled substance.

Dosage 52

Dosage Intravenous Solutions Controlled Substances FDA 52

The FDA Law Blog

OCTOBER 20, 2024

DEA holds the popular take back event each spring and autumn. DEA and its law enforcement partners will once again host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, October 26, 2024, from 10:00 a.m. to 2:00 p.m. local time. DEA has collected over 18.5 million pounds of medication since 2010.

Controlled Substances 59

Controlled Substances 59

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. The black box warning also notes that NSAIDs like meloxicam can increase the risk of serious cardiovascular clotting events like heart attack and stroke, which can cause death.

Mayo Clinic 105

Mayo Clinic Controlled Substances Compounding FDA 105

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?

Controlled Substances 52

Controlled Substances Dosage Labelling FDA 52

The Checkup by Singlecare

MARCH 21, 2023

There are other options available to treat pain that does not improve with hydrocodone-acetaminophen or in patients who experience adverse events. NSAID use is associated with an increased risk of cardiovascular events , including the development of high blood pressure. What can I take in place of hydrocodone acetaminophen ?

Dosage 52

Dosage Controlled Substances Labelling Packaging 52

The Checkup by Singlecare

MARCH 8, 2024

Food and Drug Administration (FDA) to manage generalized anxiety disorder. Still, it is a controlled substance and comes with the risk of drug abuse and physical dependence. It is also used off-label for other forms of anxiety, like agoraphobia, panic disorders, and acute vertigo episodes.

Controlled Substances 97

Controlled Substances Communication FDA Labelling 97

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. | What is Vyvanse? What are the main differences between Focalin and Vyvanse?

Controlled Substances 52

Controlled Substances Labelling Insurance Dosage 52

The Checkup by Singlecare

FEBRUARY 11, 2025

As an anxiety medication, pregabalin is FDA approved in cats for the alleviation of situational anxiety, particularly travel anxiety or veterinary visits. Anxiety The FDA has approved Bonqat, a liquid version of pregabalin, to treat cat anxiety provoked by travel or veterinary visits. Can I give my cat pregabalin every day?

Dosage 52

Dosage Adverse Reactions Controlled Substances FDA 52

The Checkup by Singlecare

OCTOBER 1, 2024

Phentermine , which is classified as a sympathomimetic amine, is approved by the United States Food and Drug Administration (FDA) for short-term use for weight loss. It is a Schedule IV controlled substance , because it has the potential for abuse and dependence. Wegovy is FDA approved for chronic weight management.

Labelling 52

Labelling FDA Insurance Controlled Substances 52

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. Doctors often take precautions to help minimize the incidence of side effects.

Dosage 52

Dosage Controlled Substances Labelling FDA 52

The Checkup by Singlecare

DECEMBER 12, 2023

Recognition of these next-day events has led to greater caution with the drug’s use and dosing, and just as important, concerns involving side effects have called attention to drug interactions that can escalate adverse reactions. The Food and Drug Administration (FDA) even sent a special communication to call attention to this risk.

Adverse Reactions 52

Adverse Reactions Controlled Substances Labelling Communication 52

The Checkup by Singlecare

JUNE 18, 2024

Adults and children ages 12 years and older Adults and children ages 17 years and older Wegovy vs. phentermine: Conditions treated Wegovy is approved by the FDA for chronic weight management in adults and children ages 12 and older with obesity. Long-term Short-term use, up to 12 weeks at a time Who typically uses the medication?

Dosage 52

Dosage Insurance Insurance Coverage Controlled Substances 52

The Checkup by Singlecare

SEPTEMBER 20, 2023

Accutane contraindications Accutane is mandated to have a boxed warning by the Food and Drug Administration ( FDA ) and absolutely can not be used by patients who are pregnant or may become pregnant. You must agree to use one of the approved forms of birth control while taking Accutane. It is not habit-forming.

Controlled Substances 52

Controlled Substances Packaging FDA 52

The Checkup by Singlecare

NOVEMBER 8, 2022

Diclofenac sodium is a prescription medicine that is approved by the FDA. These events can happen at any time, with or without warning symptoms. NSAIDs, including diclofenac, can increase the risk of serious heart events, such as heart attack and stroke, which can cause death. Is diclofenac a controlled substance?

Controlled Substances 52

Controlled Substances FDA Labelling 52

The FDA Law Blog

APRIL 17, 2025

DEA holds the ever-popular drug take back event each spring and autumn. DEA and its law enforcement partners will once again host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, April 26, 2025, from 10:00 a.m. to 2:00 p.m. local time. DEA has collected over 19.2

Controlled Substances 59

Controlled Substances 59

The Checkup by Singlecare

DECEMBER 1, 2022

Diclofenac is approved by the United States Food and Drug Administration (FDA) and is available by prescription only, although topical diclofenac is now available both by prescription and over-0the-counter. Used to treat mild to moderate pain from arthritis and other conditions, it is not a controlled substance or narcotic.

Dosage 52

Dosage Controlled Substances Medication Labelling FDA 52

PQA

SEPTEMBER 9, 2022

UMSOP and the FDA, through COMmunity Mistrust and Institutional Trustworthiness to Advance Health EQuity Research (COMMIT-EQ), seek to better understand this challenge and ameliorate it for future COVID-19 vaccine development to better ensure vaccines are safe and effective for all communities. Register today!

Community Pharmacies 52

Community Pharmacies Vaccines Controlled Substances FDA 52

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 59

Controlled Substances FDA 59

The Checkup by Singlecare

DECEMBER 31, 2024

He warns that dosing these drugs together increases the risk of adverse events. Vyvanse and Adderall are both approved by the Food and Drug Administration (FDA) for ADHD and belong to the same drug class. Vyvanse might pose less of an addiction risk Both Vyvanse and Adderall are controlled substances. However, Drs.

FDA 96

FDA Dosage Controlled Substances Insurance 96

The Checkup by Singlecare

JUNE 1, 2023

Phentermine is a derivative of methamphetamine and, as such, remains a controlled substance in the U.S. These adverse events result from phentermine’s action in the central nervous system. Long-term use of phentermine could lead to increased risk and the occurrence of adverse events.

Dosage 75

Dosage Controlled Substances Labelling FDA 75

The Checkup by Singlecare

JANUARY 20, 2025

Although it is approved by the Food and Drug Administration (FDA) for major depressive disorder (also known as clinical depression) in adults, it is sometimes prescribed off-label to treat anxiety. Lorazepam (generic Ativan) is a fast-acting drug that is FDA approved for anxiety disorders, anxiety-induced insomnia, and long-lasting seizures.

Labelling 98

Labelling Controlled Substances Insurance FDA 98