Tag: Drug regulation

The initial U.S. approval for certain uses of atropine sulfate was granted in 1960. However, the long and complex history of atropine's medical use and FDA regulation means the answer to the question, "When was atropine FDA approved?" depends on the specific formulation and indication.

While pure atropine injections and eye drops are not controlled, a significant distinction exists in its legal status when it is combined with other active ingredients. It is this dual classification that often leads to confusion regarding whether **is atropine a controlled substance** and subject to federal scheduling by the Drug Enforcement Administration (DEA).

On February 21, 2025, the U.S. Food and Drug Administration (FDA) officially declared the national shortage of Ozempic and Wegovy resolved, triggering a cascade of regulatory actions that directly impact what will happen to compounded semaglutide. This decision has led to a major crackdown on compounding pharmacies that have been producing unauthorized versions of the popular weight-loss and diabetes medication.

Biologic drugs accounted for 46% of all drug spending in the U.S. by 2018, disproportionate to their prescription volume, which is a key reason **why are biologics controversial?**. Unlike small-molecule drugs, these complex treatments derived from living organisms carry significant baggage related to cost, safety, and ethical concerns.

The U.S. Drug Enforcement Administration (DEA) places controlled substances into five schedules based on their potential for abuse and accepted medical use. Understanding **what medications are controlled substances** is crucial for patients and healthcare providers alike to ensure proper prescribing, handling, and use.

Diazepam, a benzodiazepine commonly known by the brand name Valium, is classified as a Schedule IV controlled substance by the DEA. Therefore, is a prescription required for diazepam, and purchasing or possessing it without a valid one is illegal and unsafe.

In a unanimous 2023 vote, an FDA advisory panel declared oral phenylephrine ineffective as a nasal decongestant. This decision explains why is the FDA banning phenylephrine, prompting the agency to propose its removal from over-the-counter products after decades on store shelves.

According to the U.S. Food and Drug Administration (FDA), a robust, multi-stage evaluation process is required before a new drug can be approved for sale. Knowing how to know if a medication is FDA approved is a critical step for patients and consumers to ensure the safety and effectiveness of the products they use.

Despite being used in many countries for decades to treat angina, trimetazidine has never been approved by the US Food and Drug Administration (FDA). This article delves into the critical factors, including strict safety and efficacy requirements, that explain why is trimetazidine not used in the US.

While not universally banned, Pepto-Bismol, or its active ingredient bismuth subsalicylate, is restricted in several countries due to serious health risks. Concerns over potential neurotoxicity from bismuth and salicylate poisoning, particularly Reye's syndrome in children, have led to significant regulations and even outright bans in some parts of the world.