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Other Compounding Industry News

Other Compounding Industry News

5/22/2022 – PCCA’s compounding pharmacist members call on Congress to protect patient access to compounded medication

Houston, Texas, May 12, 2022 (GLOBE NEWSWIRE) — Compounding pharmacists nationwide are calling on lawmakers to thwart efforts that pharmacists fear would restrict patient access to compounded medications.

PCCA leaders said that as part of the group’s ACT Virtual Legislative Conference, compounding pharmacists nationwide are scheduled to meet Thursday with 110 members of Congress to raise concerns about regulations that potentially will disrupt their pharmacies and the patients they serve.

“Without congressional support of these issues, the future of personalized medicine is at risk,” said PCCA Vice President of Public Affairs, Communications, Education and Human Relations Lizzie Harbin. “Human and animal patients need access to all available treatment options to live healthier, better lives. Prescribers should not be limited in their ability to treat patients as individuals, and pharmacists should be able to lawfully fill prescriptions for needed treatments.”

Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioner’s prescription in which individual ingredients are mixed together in the exact strength and dosage form required for the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.

More than 60 compounders are participating in this year’s conference to share critical patient access issues centering around compounded hormones and animal patient compounded medications with members of Congress.

A July 2020 Food and Drug Administration-commissioned and funded report (bit.ly/nasem-bhrt) issued by the National Academies of Sciences, Engineering, and Medicine (NASEM) recommends prescribing restrictions for compounded hormones and that the most commonly compounded hormones be considered for FDA’s Difficult to Compound list – meaning anything on that list would be illegal to compound. If implemented, these recommendations would restrict or eliminate patient access to compounded hormones, negatively impacting millions of women and men nationwide. While a range of evidence was provided to the NASEM committee by stakeholders, the committee elected to base their findings on just 13 studies, without a formal meta-analysis and without full consideration of all of the available evidence.

For an April 2022 article (bit.ly/NAMS-cBHT22) published in Menopause, the peer-reviewed journal of the North American Menopause Society (NAMS), PCCA’s Yi Liu, PharmD, PhD, Daniel Banov, MS, RPh, and A.J. Day, PharmD, executed a comprehensive process that reviewed more than 3,000 full-length papers to identify 29 randomized control trials examining the use of compounded bioidentical hormones by over 1,800 patients. Titled “Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials,” this article provides new insights on existing safety and efficacy data on compounded hormones. The publication of this latest article in Menopause shows that there is more evidence available than what was identified and considered by the NASEM committee and the evidence review process was not thorough, which contradicts and casts doubt on the scientific merit of the conclusions.

Another critical patient access issue involves compounded medications for veterinary patients. In April 2022, the FDA finalized guidance titled Compounding Animal Drugs from Bulk Drug Substances: Guidance for Industry (GFI) #256 (bit.ly/gfi-256), which adds unnecessary uncertainty, builds upon flawed concepts and ultimately restricts access to critical compounded medications for animal patients. The guidance is outside of the FDA’s statutory authority and would limit compounding to starting with FDA-approved products except in limited situations.

During the Thursday meetings, compounders will ask their members… READ MORE

 

 

2/2/2022 – Fagron strengthens position in US with acquisition of Letco and divestment of non-core activities

AUSTIN, TexasFeb. 2, 2022 /PRNewswire/ — FAGRON NORTH AMERICA HEADQUARTERS – Today, Fagron, the world leader in pharmaceutical compounding, announced it has reached an agreement to acquire Letco Medical (Wayne, PA). Letco is a supplier of pharmaceutical raw materials, equipment, and other materials that support compounding, with expected sales of approximately $40 million and EBITDA margin of around 11% in 2021. The acquisition price is $34 million.

Fagron also sold 80% of its contract manufacturing business unit to a syndicate including Signet Healthcare Partners, Bionpharma, Inc and GMS Capital Partners LLC today. This business unit provides contract manufacturing and private label services for consumer healthcare companies and retailers in the United States and generates around $20 million in annual sales. The consideration for the divestment amounts to $6 million, of which $4 million in cash and $2 million in a seller’s note, and an additional $4 million in milestone payments.

Rafael Padilla, CEO of Fagron: “We are very pleased to acquire Letco. Together, our companies will form a strong combination with a broad product portfolio, a strong customer base and excellent growth opportunities. With the acquisition of Letco, Fagron strengthens its position in Brands & Essentials in the United States. This brings us a step closer to realizing our ambition to be the market leader in this segment in the countries where we operate. We look forward to welcoming the Letco employees to the Fagron family. At the same time, the divestment of our contract manufacturing business accelerates our focus on creating the future of personalizing medicine.”

Andrew Pulido, President, Fagron North America added, “Letco is a great addition to our Brands & Essential business in North America, with its complementary product portfolio. By combining our businesses, we are excellently positioned to grow further, provide opportunities for our employees, and offer industry leading service for both our customers and the millions of patients they serve each year. We can’t wait to get started with the combined team. The carve out of our contract manufacturing business unit allows us to focus on our core activities. We look forward to supporting the… READ MORE 

 

 

1/12/2022 – Medisca Signs Deal as Exclusive Global Distributor outside the USA & Israel for the Padagis Line of ORA Products

MONTREAL–(BUSINESS WIRE)–On December 9, 2021, Medisca entered into an exclusive global manufacture, supply, license and distribution agreement with Padagis (formerly, the Rx Division of Perrigo) for their ORA Product Line consisting of the following Padagis products in finished form: ORA-Plus®, ORA-Sweet®, ORA-Sweet® SF, ORA-Blend®, and ORA-Blend® SF. With this, Medisca has exclusive distribution rights on all global markets except the United States and Israel, and non-exclusive distribution rights with contractual benefits in Australia.

“Partnering with Padagis is another important step in expanding our reach, as we continue to build the power of Medisca brands into a global trailblazer across the pharmaceutical compounding, scientific lab, cosmetic, and other healthcare industries.”

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“This exclusive agreement reinforces Medisca’s commitment as a pioneer in personalized medicine around the world,” says Panagiota Danopoulos, Senior Vice President Global Strategy & Innovation, Medisca. “Partnering with Padagis is another important step in expanding our reach, as we continue to build the power of Medisca brands into a global trailblazer across the pharmaceutical compounding, scientific lab, cosmetic, and other healthcare industries.”

Developed over 20 years ago by Paddock Laboratories, which was acquired by Perrigo in 2011, ORA products are manufactured by Padagis in Minnesota and are the longest-standing compounding oral vehicles on the market, with over 150 stability studies to support their use. In fact, this unmatched study portfolio is key to why many view ORA products as the go-to compounding oral vehicles across the globe. Outside of compounding, the ORA brand continues to make its mark, found in department stores as over the counter products and included as part of FDA-approved... READ MORE