Remove Compounding Remove Definition Remove Dosage
article thumbnail

FDA Posts Slate of Seven Warning Letters Following Company Inspections

PharmTech

While FDA warning letters generally do not authorize the execution of any definitive actions by the agency, they do specify actions that may be taken if FDA’s suggestions and requests are not adhered to, usually to be communicated by a company within a window of 15 business days of receipt of FDA’s letter.

FDA
article thumbnail

Out of Shortage, Into Controversy: The Fight Over GLP-1 Compounding

Pharmacy Times

Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks. The definition of "essentially a copy" is pivotal, influencing compounding practices and legal interpretations.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The GLP-1 Gold Rush: Why Compounded Alternatives Are a Risky Bet

Pharmaceutical Commerce

1 In response to this immense demand, coupled with high costs and accessibility issues, compounded alternatives have emerged as a seemingly pragmatic solution. However, these compounded GLP-1s are creating a significant, often underestimated, legal, reputational, and financial minefield for startups and the broader life sciences industry.

article thumbnail

What You Need to Know as a Breastfeeding Hashi’s Mama

The Thyroid Pharmacist

Women with treated thyroid conditions will likely need to adjust their medication dosage, perhaps multiple times. You can also try using oxytocin nasal spray that you can get prescribed and compounded by your compounding pharmacist, taking Epsom salt baths, or using essential oils like lavender and clary sage. [60]

article thumbnail

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

article thumbnail

Can berberine help with weight loss?

The Checkup by Singlecare

Berberine is a yellow alkaloid compound extracted from several plants such as goldenseal, Oregon grape, and tree turmeric. The amount of weight loss [with berberine] definitely varies,” says Tracy Eliszewski , a nurse practitioner with Forum Health in Fitchburg, Wisconsin. Does berberine help with weight loss?

article thumbnail

Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Many times, people have been able to eliminate their symptoms and reduce their dosages of medications. 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.