STAT

JULY 26, 2023

One of the largest compound pharmacy operations in the U.S. For example, there were 100 instances between November 2022 and March 2023 in which the company found what the FDA called a “significant number” of bacteria, yeast, mold, and other spore-forming organisms.

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Compounding Hospitals Compounding Pharmacies FDA 98

pharmaphorum

MAY 5, 2021

A medicine based on MDMA – the active ingredient in recreational drug ecstasy – is on the cusp of FDA approval as a treatment for post-traumatic stress disorder (PTSD), according to the organisation developing it. . A second is underway in 100 subjects and if positive could result in a green light for the therapy in 2023.

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STAT

OCTOBER 31, 2024

Food and Drug Administration drug shortage list as of Wednesday , raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs, STAT reports. The number of layoffs in the U.S.

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Compounding Pharmacies FDA Compounding Packaging 109

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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FDA Documentation Method Validation Packaging 98

The FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. Some takeaways on those efforts that we gleaned from the report: Compounding. Drug Supply Chain. Clinical Trials.

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Compounding FDA Communication 59

Pharmacy Times

JUNE 20, 2025

Related Videos Related Content Advertisement June 20th 2025 FDA Approves Dupilumb for Treatment of Bullous Pemphigoid Aislinn Antrim, Managing Editor May 28th 2025 Pharmacy Focus: Navigating Seasonal Allergies Luke Halpern, Assistant Editor Derek Webb, PharmD June 20th 2025 Self-Care Measures for Preventing and Managing Dysmenorrhea Yvette C.

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Vaccines Immunization Compounding Pharmacies Hospitals 65

The FDA Law Blog

SEPTEMBER 11, 2024

Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. FDA starts by setting the limit of what it views as acceptable intake (AI) limits, so that manufacturers and applicants can know what targets they should hit. By John W.M.

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FDA Documentation Compounding 105

The FDA Law Blog

FEBRUARY 28, 2023

THC acetate esters are different than delta-9-THC, the psychoactive compound found naturally in the cannabis plant. 13, 2023). Dr. Boos explained that delta-9-THCO and delta-8-THCO have similar chemical structures and pharmacological activities as compounds in the cannabis plant so they fall within the definition of THC.

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Controlled Substances Compounding 58

The Checkup by Singlecare

MARCH 25, 2024

Unlike Ozempic, which is FDA approved to treat Type 2 diabetes, Wegovy is approved for weight loss in patients with a body mass index (BMI) of 30 or higher and in patients with a BMI of 27 or higher who also have a weight-related medical condition like Type 2 diabetes, high blood pressure, or high cholesterol.

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Compounding FDA Insurance Compounding Pharmacies 98

European Pharmaceutical Review

DECEMBER 13, 2022

They provided this compound to John Hopkins University who received a grant of nearly $4 million from the National Institutes of Health (NIH) for their smoking cessation study in the US – the first time in 50 years the US government has funded a study evaluating a psychedelic compound for therapeutic use.

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Compounding FDA 105

STAT

JANUARY 25, 2024

 One person also experienced hypoglycemia in 2023 after injecting a compounded version of Ozempic, said the organization, which represents 55 regional poison centers across the country and works with the U.S. … Three people sought medical treatment for dangerously low blood sugar in the U.S.

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Labelling Compounding FDA 108

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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FDA Compounding Pharmacies Labelling Compounding 59

European Pharmaceutical Review

JANUARY 29, 2024

In the published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. The guideline states that compounds “at or above the AET must be reported for toxicological risk assessment.”

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Compounding FDA 98

pharmaphorum

JANUARY 11, 2023

Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-transcriptional regulation (i.e.

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Compounding FDA 105

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.

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Dosage Compounding Labelling FDA 52

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

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Compounding Documentation Insurance Immunization 98

The FDA Law Blog

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What is FDA doing about NDRSIs? Seek, and ye shall find, so FDA hopes. By John W.M. Claud & Sara W.

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FDA Compounding 52

Pharmacy Times

JUNE 20, 2025

News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)

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The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

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Insurance Insurance Coverage FDA Documentation 104

Hospital Pharmacy Europe

MARCH 21, 2024

Supporting the successful compounding of drugs with 3D printing processes has the potential to not only fulfil unmet patient needs but also drive efficiencies in hospital pharmacies. 2 The first drug produced through printing technology based on inkjet on powder was approved by the US FDA in 2015.

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Hospitals Compounding Dosage FDA 111

The FDA Law Blog

AUGUST 14, 2023

OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance. One inspection resulted in FDA’s securing a consent decree to restrict or shut down operations, and two resulted in an “untitled letter,” which is not available to the public on FDA’s website.

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FDA Dosage Compounding 52

European Pharmaceutical Review

OCTOBER 19, 2023

Additionally, in June 2023, the world’s largest radionuclide production facility of lutetium-177 opened in Germany. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use. Recent advancements for radiopharmaceuticals in oncology include a $1.4

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Chemotherapy Compounding Immunization FDA 105

Pharmafile

FEBRUARY 21, 2023

Published date: 21/02/2023 Summary: ● This is the first time the FDA has given IND approval for a Phase IIb study of a short-acting psychedelic like 5-MeO-DMT (Mebufotenin). The study will take place across 40 investigator sites in 7 different countries, with study results expected in 2024. read more

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FDA Compounding 40

PharmaShots

MARCH 3, 2023

Shots: The US FDA has accepted the NDA for Priority Review of ADX-2191 (methotrexate injection) for PVRL. The therapy received ODD from the US FDA for PVR, PVRL, and retinitis pigmentosa Ref: Aldeyra | Image: Aldeyra Related Post:- Aldeyra Therapeutics Reports the US FDA Acceptance of NDA for Reproxalap to Treat Dry Eye Disease

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FDA Compounding 40

Pharmafile

JANUARY 5, 2023

Published date: 05/01/2023. Summary: • TMP-301 (formerly HTL0014242) is a potent, selective, and orally available mGluR5 negative allosteric modulator (NAM) candidate discovered by Sosei Heptares and out-licensed to Tempero Bio • Phase 1 study in healthy volunteers expected to begin in Q1 2023 with support from a US$5.3M read more.

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FDA Compounding 40

The Checkup by Singlecare

APRIL 17, 2024

Over 80 million Americans received Medicaid assistance in 2023, and it sometimes covers Mounjaro for diabetes treatment. Look into compounded options (but be careful). Medicaid is a federal- and state-funded program that provides free or steeply discounted health insurance, often including coverage for prescription drugs.

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Insurance Insurance Coverage Compounding Pharmacies Compounding 98

The Checkup by Singlecare

SEPTEMBER 28, 2023

Supplement with turmeric Curcumin is the main compound of the herb turmeric, and according to Dr. Garcia-Ibáñez, it works as a powerful antioxidant and anti-inflammatory. Garlic Garlic does contain anti-inflammatory compounds that, in theory, might reduce congestion. StatPearls (2023) Nasal Congestion. That’s because only 0.5-2%

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Compounding Immunization Mayo Clinic Dosage 105

European Pharmaceutical Review

JUNE 29, 2023

This challenge is further compounded by increasingly complex drug formulations and global ingredient supply chains that stretch manufacturers’ capabilities in testing and control of impurities. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs. Internet] 2023.

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FDA Compounding 98

ISPE

APRIL 13, 2023

1 More recently, regulators like the FDA have increasingly promoted the benefits of modeling (e.g., For a more in-depth review of these topics, including Q&A, register for the ISPE webinar “Advance Biopharma Tech Transfer Using Process Modeling & Simulation”, on Thursday, 4 May 2023 at 1000 ET. Register Now! 1 Harrison, Roger G.,

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Compounding FDA 98

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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FDA Documentation Pharmaceutical Companies Pharmaceutical Companies 103

The Thyroid Pharmacist

JUNE 30, 2023

You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. LDN can be taken in the form of a compounded tablet, capsule, liquid, or transdermal formulation. It’s also best to work with a compounding pharmacy that can help you titrate your dose correctly.

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Compounding Immunization Compounding Pharmacies Adverse Reactions 98

pharmaphorum

FEBRUARY 24, 2021

That compound (previously called TAK-580) was taken into a phase 1/2b trial in children with the brain cancer glioma before the Japanese drugmaker returned the rights after a review of its pipeline assets. It says the FDA has suggested that study could form the basis of a regulatory filing if response rate data are positive.

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Chemotherapy Compounding FDA 83

The Checkup by Singlecare

DECEMBER 1, 2023

For people with Type 2 diabetes, Ozempic is a game-changer: This FDA-approved drug not only lowers blood sugar but can also help people lose weight. UC Davis Health (2023) Diabetes , World Health Organization (2023) GLP-1 Agonists , Cleveland Clinic (2023) Fats. MedlinePlus Curious About Ozempic?

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Packaging Compounding FDA 105

The Checkup by Singlecare

OCTOBER 11, 2023

Phenylephrine In September 2023, the FDA announced that a common decongestant found on shelves, phenylephrine, is not actually effective to decrease congestion. Some studies suggest curcumin, the active compound in turmeric, may even have antiviral properties. Here’s what to skip. or make an anti-inflammatory chicken soup.

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Mayo Clinic Immunization FDA Compounding 106

pharmaphorum

JUNE 12, 2025

These closures, compounded by the decline of independent pharmacies, create a critical gap in care. Image Maggie McCullough 12 June, 2025 pharmacy deserts Bookmark this Oncology ImmunityBio’s ANKTIVA & FDA Expanded Access: Transforming bl. These closures put medication access, affordability, and adherence at greater risk.

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Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Insurance Coverage 59

DiversifyRx

APRIL 4, 2024

Help your patients access the hottest weight loss medications with these semaglutide and tirzepatide resources for independent pharmacy owners, whether you compound or not. Is It Legal To Compound Semaglutide and Tirzepatide? Some states might have you check the list every day you compound with either of these APIs (i.e.,

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Independent Pharmacies Compounding Compounding Pharmacies FDA 40

PharmTech

JUNE 10, 2025

Regulatory and Policy Implications Key Takeaways ·ACIP overhaul disrupts vaccine approval timelines, posing risks to clinical trial planning, FDA readiness, and seasonal launch strategies. The news follows announcements in March of a restructuring to include the reduction of HHS workforce by 10,000 full-time employees.

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