Flex Certification only applies to CGMP, Licensed 503B manufacturing facilities
All compounds are not created equal
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Look for the FDA - NDC code & the Flex Certified™ Label
503A's are regulated by the state. Three states have banned 503A compounds because of lack of regulatory and clinical oversight. The Active Pharmaceutical Ingredient (API)- Semaglutide, is often research grade and or Semaglutide salts.
503B's are regulated by the FDA and their facilities are FDA-CGMP Certified. Additionally, the Active Pharmaceutical Ingredient (API) - Semaglutide, is FDA approved commercial products for FDA short supply list.
The Flex Certified™ difference.
We do NOT source from 503A compound pharmacies.
FDA Regulated Materials - APIs
API is sourced for human-consumption unlike 503As that source for research purposes.
FDA-registered National Drug Code
All Flex Certified™ compounds have a FDA-registered NDC, unlike 503A drugs.
FDA-enforced CGMP Certified Facility
All Flex Certified™ compounds are manufactured from facilities following CGMP guidelines.
3rd Party Testing & Labs
All Flex Certified™ compounds are 3rd party tested for quality, sterility & stability.
3rd Party Facility Inspections
All Flex Certified™ compounds are manufactured in facilities that are 3rd party inspected.
What is the difference between 503A and 503B compound pharmacies?
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503A pharmacies compound medications according to United States Pharmacopeia (USP-795-797) standards and are regulated by the states. 503A drug products are only for home use.
Lab and often
Manual Filling
503A
Compound medications according to Current Good Manufacturing Practices (cGMP) and are held to more rigorous standards than 503A pharmacies. 503B pharmacies can also sell sterile, compounded products in bulk.
Outsource Manufacturing Facility with Automated Filling & FDA oversight.
503B
FDA - National Drug Code
All of Flex Certified™ compounds have NDCs. The FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Drug establishments are required to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed for sale in the U.S. at their facilities. Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA’s identifier for drugs. FDA publishes the listed NDC numbers in the NDC Directory which is updated daily.
Flex Certified™ - Good Manufacturing Practice (GMP) is a quality assurance standard for pharmaceutical manufacturing.
All Flex™ Certified compounds are sourced from FDA CGMP facilities. Current Good Manufacturing Practices (CGMP) are regulations set by the FDA to ensure the consistent production and control of products. These regulations apply to many industries, including pharmaceuticals, food and beverage, medical devices, and dietary supplements.
Active Pharmaceutical Ingredients (APIs) - FDA Approved Commercial Products from FDA Drug Master Files (DMFs).
All Flex Certified™ Active Pharmaceutical Ingredients (APIs) for our GLP-1s are sourced through FDA DMFs and are never research grade.
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs do the following:
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Allow parties to reference material without disclosing DMF contents to those parties.
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Are not required by statute or regulation.
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Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).
3rd Party Testing
Batch testing of endotoxin, sterility and potency beyond use date and extensions confirmation.
All Flex Certified™ compounds are tested by 3rd Party approved testing partners for endotoxin, sterility and potency. All testing is supplemented with an expiration date and extensions. We have developed one of the most rigorous Standard Operating Procedures for our products. Get the Flex Certified™ solution.
We ship to all 50 states
Our Chief Chemist and Medical Affairs Manager
Bill Fixler, PharmD
Letter from Bill on FDA warning to 503A compounders
As we discussed, I first wanted to address the attached letter referencing Semaglutide salts from the FDA in October of 2023. The purpose of the FDA letter was to inform the National Association of Boards of Pharmacy (NABP) that during inspections the FDA was starting to notice compounders utilizing Semaglutide Acetate and Semaglutide Sodium (ie the salts) in substitute for Semaglutide (base). As you know, salt forms of molecules can directly effect their chemical behavior, properties, and clinical attributes. For lack of a better term, they are different drugs all together. We are unaware why these salts are being used so frequently, however, I can only surmise that these are 503A compounders that either; did not know the difference, was more easily accessible or was lower priced then the base form. This material would have most likely come from questionable and non FDA registered API suppliers that brought in for research purposes only as there is no human indication for salt form.
With all that said, the FDA's main concern is that anyone who is compounding or helping out with the national shortage should be using the exact form in the FDA approved commercial products, the Semaglutide base. Flex Certified Products, not only utilize the pure Semaglutide base, but also use DMF material for all API. This adds an extra level of comfort to those purchasing and using our product. Our DMF material has also been signed off as the material to be used during Flex Certified™ ANDA filing procedures that have already begun, which will eventually bring a generic Semaglutide to commercial market.
Compounding Semaglutide (base) while the commercial products are in FDA shortage is the only lawful way to go about providing this product. We import our own API and declare for human consumption. We believe we are the only company bringing in API specifically for compounding to assist in filling the shortage and not for research purposes as most every compounding pharmacy is doing.
Flex Certified™ partners have established state-of-the-art Sterile Injectable Drug Manufacturing facility equipped with human-less sterile fill machines utilizing robotics, within ISO-5 isolators. Our Flex Certified™ facility is one of the only few pharmaceutical manufactures with a 503B license and the only one that is making Semaglutide injection. Unlike compounders that adulterate the product by include additional actives, our product only has Semaglutide.
Subsequent audits by USFDA CDER, CDRH, and Outsourcing Facilities teams in April 2019 resulted in approvals with no 483 observations related to Outsourcing Facilities. Our Flex Certified™ facility produces Sterile Injectable Drugs for both FDA-approved products and 503B drug shortage products using cutting-edge robotic technology and an FDA-approved manufacturing facility. This is crucial, given that many compounding pharmacies employ traditional Laminar Flow Hoods and manual operations, which pose a higher risk of contaminations and have been associated with sterility and contamination issues in the industry.
Importantly, none of the Flex Certified™ facilities have had any market complaints or recalls, a testament to the effectiveness of our high-end technology.
I am dedicated to ensuring our products meet the highest efficacy, rigorousness and quality possible.
