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”). We note that in December 2020, the same U.S.

Controlled Substances 52

Controlled Substances General Merchandise Stores Grocery Stores Compounding 52

The Checkup by Singlecare

MARCH 1, 2024

But determining whether someone needs it is challenging, and because it’s a controlled substance, getting a prescription can be, too. Food and Drug Administration (FDA) classifies it as a category C drug , meaning animal studies have found adverse effects on the fetus. Do you need an Adderall prescription?

Controlled Substances 97

Controlled Substances Mail-Order Pharmacies FDA Labelling 97

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 59

FDA Controlled Substances Hospitals 59

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

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 52

FDA Labelling Controlled Substances Communication 52

The Checkup by Singlecare

JULY 30, 2023

Xanax was initially approved by the United States Food and Drug Administration (FDA) in 1981 and is still popular today. As of 2020, alprazolam is the 37th most prescribed medication in the country. New brand-name drugs go through extensive testing in order to be approved by the FDA. This is called off-label prescribing.

Dosage 52

Dosage Labelling FDA Controlled Substances 52

The Checkup by Singlecare

DECEMBER 8, 2022

Although it’s approved by the Food and Drug Administration (FDA) for the treatment of hypothyroidism, Dr. Soliman explains that it’s often used for off-label issues like low energy and goiter. . It’s classified as a Schedule II controlled substance due to its high potential for misuse and dependence, explains Dr. Soliman.

Dosage 98

Dosage Controlled Substances Labelling Immunization 98

The Checkup by Singlecare

MAY 8, 2023

Between 1999-2020, more than 564,000 people died from an overdose involving any opioid medication, including both prescription and illicit opioids. Ultimately, as a controlled substance, tramadol poses risks of abuse, diversion, dependence, and withdrawal. What can I take in place of tramadol?

Controlled Substances 52

Controlled Substances Dosage Labelling FDA 52

BuzzRx

NOVEMBER 11, 2022

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. However, topical diclofenac gel ( Voltaren Arthritis Pain ) is available over the counter to treat arthritis pain in various joints.

Dosage 52

Dosage Intravenous Solutions Controlled Substances FDA 52

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 105

Mayo Clinic Controlled Substances Adverse Reactions Dosage 105

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 59

FDA Hospitals Dosage Controlled Substances 59

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 52

FDA Mayo Clinic Dosage Controlled Substances 52

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 75

Immunization Compounding Compounding Pharmacies Labelling 75

The FDA Law Blog

NOVEMBER 21, 2024

Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. The federal telemedicine flexibilities (i.e., The federal telemedicine flexibilities (i.e.,

Controlled Substances 52

Controlled Substances FDA 52

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. By Larry K.

Controlled Substances 59

Controlled Substances FDA 59