WAYNE, Pa., June 10, 2019 /PRNewswire/ -- On June 7, 2019, the Federal Food and Drug Administration (FDA) issued a public statement related to proper use of bulk ingredients, specifically for compounded sterile injectable dosage forms. Letco Medical (Letco) agrees with the FDA's concern regarding the appropriate use of bulk substances labeled as dietary supplements. Dietary supplements play a critical role in the management of numerous health conditions and are used by physicians and pharmacies to treat patients. We applaud the work by the FDA to ensure patients have access to compounded medications, whether prepared with traditional active pharmaceutical ingredients or dietary supplements. When used properly and in accordance with their label, Letco's products, including dietary supplements, are appropriate for use in compounding.
The FDA's June 7th statement was in response to adverse events related to an injectable compounded formulation that we understand and believe was prepared, released and distributed by Enovex Pharmacy of Glendale, California, using a dietary supplement ingredient purchased from Letco. Enovex Pharmacy initiated a recall on or about January 11, 2019, of the 200 mg/mL L-glutathione sterile injectable drug product compounded in its pharmacy. No recall of Letco's L-glutathione bulk ingredient occurred or was otherwise requested by any entity. Additionally, the California Board of Pharmacy informed Letco that Enovex Pharmacy conducted no analytical testing before releasing its compounded formulation to consumers. As the FDA further clarified in their statement, "The L-glutathione powder the pharmacies received was labeled with "Caution: Dietary Supplement" and should not have been used to compound sterile injectable drugs."
On May 20, 2019, the FDA completed a comprehensive 14-day audit of Letco's FDA-registered Decatur, Alabama repackaging facility. Scope of the audit included a review of operations, quality systems, and an exhaustive assessment of Letco's labeling and certificate of analysis procedures. When the audit concluded, the FDA issued no Form 483 inspection observations.
As the premier supplier to compounding pharmacies in the United States, Letco offers a wide range of programs and services to assist with our customers' regulatory compliance, including guidance on the proper use of dietary supplement ingredients. In addition to market-leading product quality, thousands of compounding pharmacies rely on Letco daily for the following services:
Compounding Support Services – Staffed by industry-leading compounding experts and provided free of charge to all Letco customers, Letco provides formulas, formulation support, and real-time advisory services to pharmacies on a range of compounding-related topics, including proper use of dietary supplements. During the last year alone, Letco's Compounding Support Services Team responded to more than 28,000 customer inquiries.
Education Value Program – Letco provides customers access to industry-leading, hands-on ACPE-accredited education and training programs conducted in a fully functional and sterile compounding lab. Examples of accredited training include Fundamentals of Compounding and Comprehensive Sterile Compounding.
Laboratory Services Program – With the testing of finished compounded medications being critical to the safety of the pharmaceutical supply chain, Letco offers exclusive access to a partnership program with one of the leading analytical laboratories in the United States to test sterile and non-sterile compounded medications prior to market release.
Regulatory Solutions Program – Letco provides a wide range of regulatory consulting services, including pharmacy process and compliance audits, standard operating procedure development, and staff training, to ensure compounding pharmacies are meeting or exceeding regulatory requirements and consistently delivering safe products to consumers.
If you have questions or concerns about the proper use of any Letco product or the services we provide to support compounding pharmacies, please contact us at 877-538-2679.
About Letco Medical, L.L.C.
Letco Medical, L.L.C. ("Letco Med"), a 100% employee-owned company headquartered in Wayne, PA, is the supply partner of choice for profit-conscious compounding pharmacies everywhere. Letco Med has invested heavily in building a company that can serve the needs of compounding pharmacists today, tomorrow and into the future, with a full line of products and complementary programs and services. With a dedicated focus on the U.S. compounding market, Letco Med provides a wide and comprehensive portfolio of safe and consistent top-quality chemicals, compounding supplies, and equipment at highly competitive prices. In addition, Letco Med carries a deep assortment of dosage forms and delivery systems.
Since its inception in 1993, Letco Med has earned and built a reputation as one of the most innovative companies in the compounding industry. Letco Med is focused on unwavering quality, exemplified by the company's industry-leading quality assurance programs and stringent quality control procedures.
For more information, visit www.letcomed.com.
SOURCE Letco Medical