Latest news with #compoundingpharmacies
Vogue Arabia
a day ago
- Health
- Vogue Arabia
You Can Get Ozempic Online Without a Prescription. Is it Safe?
'In short, compounded semaglutide is not equivalent to the FDA-approved version in terms of quality assurance, clinical data, or regulatory,' Dr. Goulden says. To make matters worse, he adds that some compounding pharmacies are taking advantage of the Ozempic shortage. 'When I see a patient come to my office who was started on a compounded version of medication through an online platform, they are often unaware of what the medication actually is, what dose they are taking, and sometimes they are taking it multiple times a week or at unapproved intervals so this can create some confusion,' adds Dr. Lofton. 'This is also very dangerous when someone has a side effect and has to present to a hospital because we can't tell what they are taking exactly.' Is Any Online Ozempic Option Safe? While there are horror stories of people getting sick from semaglutides they've bought off of TikTok, there are other online platforms that offer somewhat of a happy – and safer – medium. Telehealth company Hims & Hers, for instance, provides consumers with easy access to GLP-1 medications through licensed professionals without much wait time. 'GLP-1s have emerged as one of the most promising tools in obesity medicine, offering hope to those who haven't found success with traditional approaches,' says Jessica Shepherd, MD, board-certified OB/GYN and Hers Chief Medical Officer. 'That's why we expanded our program to integrate the power of GLP-1s into a model designed not just for prescriptions, but for long-term success.' The process of obtaining Ozempic and other similar drugs through Hers is pretty straightforward. Dr. Shepherd explains that patients will fill out an in-depth online questionnaire about their medical history, weight journey, goals, and lifestyle. A licensed provider will review it (this can take as little as a few hours), and if the patient is the right candidate for the drug, the practitioner will write a prescription for the recommended weight loss medication and come up with a personalized health plan to support them. This includes check-ins, 24/7 access to a care team for any questions, and educational resources and support with their nutrition, mental health, and physical well-being through the app. Because everything is done virtually, Dr. Shepherd says care is flexible to 'meet people where they are and [be] responsive enough to evolve in real time.' Hims & Hers offers Ozempic, Wegovy, and other FDA-approved medications that are known to help with weight management. Until recently, they also offered compounded options to offset the nationwide Ozempic shortage and offer a cheaper option (it was reported by Quartz that it used to cost $199 a month) for those who may not be able to afford the brand label. But as of May 23, 2025, no new compounded semaglutide is legally permitted to be produced or sold. The FDA states that there are exceptions, such as an allergy to an inactive ingredient found in GLP-1s, and patients may still use compounded medication that was made before the cutoff date.
Forbes
09-07-2025
- Business
- Forbes
The Next Healthcare Arbitrage: PE And VC Bet On Compounding Pharmacies
An Ozempic (semaglutide) injection pen is seen on a kitchen table in Riga, Latvia on 06 August, ... More 2023. (Photo by Jaap Arriens/NurPhoto via Getty Images) Flush with funding and surging demand, compounding pharmacies are attracting capital from private equity firms, venture capital firms, and hospitals, reshaping the pharmaceutical power dynamic from the bottom up. This is Part 2 of a two-part series on compounding pharmacies. In A Dose Of Disruption: How Compounding Pharmacies Are Challenging Big Pharma On GLP-1 Drugs And Drug Patents, we explored how compounders are rewriting the rules on GLP-1s and drug patents. Now, we turn to the capital behind the curtain—how private equity, venture capital, and hospital systems are fueling the rise of an alternate pharmaceutical infrastructure. I. From Niche to Infrastructure: The Rise of Compounding Big Pharma has long operated like a legal cartel—protected by evergreening patents, backroom pay-for-delay deals, and control over formularies that dictate which drugs insurers and hospitals will cover. It reinforces this dominance through aggressive lobbying, public relations campaigns, and billions spent on direct-to-consumer and physician marketing. But cracks are forming. Amid persistent drug shortages and growing demand for personalization, a quieter revolution is taking hold. The Evolution of Compounding Pharmacies Compounding pharmacies, once the backrooms of mom-and-pop drugstores, are evolving into a multibillion-dollar infrastructure play. Investors are waking up to the fact that the next big pharmaceutical disruption may not come from the lab—it might come from the compounding bench. Market forecasts peg the U.S. compounding pharmacy sector at $6.31 billion in 2024, projected to reach $10.76 billion by 2033, growing at a CAGR of 6.1%. This expansion is driven by drug shortages, telehealth, chronic conditions, rising consumer demand for personalization, and increased provider interest in patient-centered care. Therapeutic Focus: Hormone therapy, dermatology, chronic pain, sexual health, pet meds, longevity and personalized medicineRegulatory Categories: FDA 503A (traditional compounders), 503B (outsourcing facilities)Key Players: Empower Pharmacy, QuVa Pharma, Leiters, VLS Pharmacy, PCCARisks: Sterility concerns, FDA scrutiny, lack of drug approval for compounded versions, state–federal oversight inconsistenciesSources: BioSpace, Nova One Advisor, FDA, company websites Compounding pharmacies address deep structural inefficiencies in the pharmaceutical system. They offer a flexible response to drug shortages and supply fragility, serve patients needing personalized or niche formulations, and operate outside the opaque pricing mechanisms dominated by just a few major pharmaceutical companies. For patients, they represent a more accessible and responsive alternative—especially in the context of rising telehealth adoption. What makes this model particularly attractive to investors is its strong financial profile. First, compounded medications often treat chronic conditions like hormone therapy or dermatological issues, creating reliable subscription-based revenue. Second, many compounders handle their own fulfillment, bypassing pharmacy benefit managers (PBMs) and wholesalers—leading to significantly higher margins. Third, customer acquisition costs (CAC) are often low, thanks to prescriber-driven referrals and integrated telehealth platforms. Finally, regulatory arbitrage allows compounders to legally operate under FDA 503A and 503B exemptions—producing medications without full FDA approval, provided they meet specific patient or clinical use requirements. The legacy image of the compounder—splitting pills behind the counter—no longer applies. Today's leaders are deeply embedded into healthcare infrastructure. These platforms don't just fill scripts—they control the entire patient experience, from diagnosis to doorstep. Vertical Integrators: Platform Partners (Non-Owners): The competitive pressure isn't just coming from startups. Giants like Amazon have entered the pharmacy space with mail-order prescriptions, fulfillment infrastructure, and its $1B+ acquisition of PillPack—reshaping consumer expectations around convenience, speed, and price transparency. While Amazon doesn't operate in compounding, its presence adds urgency for verticalized platforms to differentiate through personalization and specialty formulations. Personalized medicine is no longer limited to tailoring doses—it's becoming a cornerstone of the rapidly growing longevity economy. As wealthy consumers, biohackers, and digital health platforms chase enhanced immunity, energy optimization, and age reversal, compounding pharmacies are increasingly part of the protocol. Biohackers like Bryan Johnson—whose multimillion-dollar quest to reverse aging includes aggressive biomonitoring, nutrient tracking, and intravenous therapies—have helped bring visibility to personalized protocols. IV drips for immune support, NAD+, hydration, and energy are now offered not just in wellness clinics, but in luxury medspas, concierge practices (for optimizing IVF results and longevity), and hotel suites across major cities. Many of these formulations originate from compounding pharmacies, which supply customized injectables, infusions, or troches based on client goals and lab results. In the oncology space, personalized adjunct therapies—like low-dose naltrexone, topical pain relievers, and customized hormone or sleep aids—are often compounded to support patients alongside conventional treatment. These niche interventions highlight compounding's ability to fill therapeutic gaps that mass-manufactured drugs can't reach. The demand is scaling fast—fueled by longevity clinics, telehealth labs, personalized diagnostic startups, and medspas. Investors are beginning to recognize that compounding pharmacies are not just reactive stopgaps. They're becoming critical infrastructure for proactive, precision-driven medicine that caters to a future of biologically tuned care. Compounding pharmacies operate under FDA's 503A and 503B guidance, outside the NDA pathway. This enables them to: 1) bypass patents, 2) serve during shortages, and 3) personalize formulations. In 2023–24, compounded GLP-1s like semaglutide exploded in popularity due to shortages and affordability. Hims, Ro, and others jumped in, as detailed in The GLP-1 Revolution—Everyone (And Their Moms) Are On GLP-1s. TikTok amplified the demand. Then came the blowback: Yet demand persisted. Empower Pharmacy, a scaled 503B facility, continues to fill tens of thousands of GLP-1 scripts monthly. The sector is under growing scrutiny: Still, Empower has retained the support of respected clinicians. 'If I need something, I would get it from Empower,' said Dr. Larry Lipshultz, a urologist at Baylor College of Medicine. 'There's no question that you're dealing with a first-class operation.' He estimates Empower's alternatives are up to 80% cheaper than branded drugs—a crucial differentiator for out-of-pocket payers. Big Pharma has also seen quality missteps. Most recently, Sandoz recalled a lot of cefazolin due to mispackaging, underscoring that safety lapses are industry-wide. Private Equity: Venture Capital: Hospital Systems: This cross-capital convergence shows compounding isn't a fringe workaround—it's becoming fundamental infrastructure. As detailed in A Dose of Disruption: How Compounding Pharmacies Are Challenging Big Pharma On GLP-1 Drugs And Drug Patents, compounded medicine is redefining price, personalization, and access. If courts crack down on patent evergreening and capitalized compounders keep scaling, a decentralized, faster, cheaper alternative to Big Pharma could emerge. As compounders scale across B2B (hospitals) and B2C (telehealth), regulatory compliance becomes make-or-break. 503B compounders must demonstrate proactive compliance and high-quality controls. QuVa (Bain) and Leiters (hospital-backed) are well-positioned. Empower remains under scrutiny, even as it scales. Any major incident could reshape public trust—and investor interest. If Big Pharma is the last legal drug cartel, then compounding pharmacies are its insurgents—and PE and VC are backing them for a market coup. In this battle over price, trust, and access, the rebels aren't just disrupting—they're rebuilding.
Reuters
18-06-2025
- Business
- Reuters
U.S. judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list
June 18 - A federal judge in Texas has upheld the U.S. Food and Drug Administration's decision to remove Novo Nordisk's blockbuster drugs Ozempic and Wegovy from the drug shortage list, rejecting a challenge brought by compounding pharmacies who sought to continue making copies of the drugs.
