It's been a while since we talked about compounding. Like all healthcare topics, it's great to revisit old information and update it, or at least refresh. As the compounding industry continues to change, I think it's important that clients of JDJ Consulting understand how we are and are not involved in your decision to use and choose a compounder. First thing's first. Let's quickly review the basics of compounding.
503A vs 503B There are two types of compounding companies: 503A and 503B. Both types of organizations are registered with the FDA and both are governed by certain regulations to ensure patient safety. However, there is a difference between what each is allowed to produce and the regulations that they must abide by. 503A Compounding Pharmacies must fill orders per patient prescription. These facilities make drugs per order and are typically, but not always, smaller facilities producing less volume. 503B Outsourcing Facilities may manufacture bulk quantities of drug and fill orders with or without patient prescriptions. These facilities must follow more complex regulations and are also subject to Good Manufacturing Practice regulations. 503B Outsourcing Facilities must also follow more rigorous quality testing on their products. You can find out which facilities are 503B by looking on the FDA's Website of registered 503B's. Also, most 503B's will notate this status on their website.
How do I choose a compounder? Choosing either a 503A or 503B has some similarities. When you're considering working with a compounder, we recommend that you use this checklist during your decision making. 1. Is this facility a 503A or 503B? This is important to know later on. 2. Know what item(s) you'd like to purchase from them. Call and ask for sterility and stability testing on that product. Without asking, the compounder should be able to provide the results of those tests for their most recent batch. If they provide test results that are older than 6 months, and this is for a product that is currently being produced, this could be a concern. At this point you might question whether more recent batches had less desirable test results, or whether they've stopped producing that product but it's still "for sale". Once they provide you with the test results, they should show acceptable ranges or pass/ fail parameters on the test. You might also want to ask them whether these tests are performed "in house" or by a 3rd party lab. Keep in mind that because regulations are different for 503A's and 503B's, a 503A may not have the same test results available (there are fewer quality testing requirements for 503As). Ask the representative from the 503A what test results they perform, whether they keep product in quarantine or ship without testing, and whether they have tested shelf life (B.U.D.) on the product. 3. If you call the compounder, are you able to speak to a pharmacist in a reasonable amount of time? If a pharmacist is not readily available, how quickly can they call you back? If you're unable to get in touch with a pharmacist within 24 hours, this could be a red flag. 4. If you're considering a 503B Outsourcing Facility, check the FDA's website to make sure they're registered. Find the company on the FDA list and review the information provided. Have they been inspected yet? Was an FDA-483 Letter issued? If yes, click on "YES" and view the letter. This will describe significant objectionable findings from the FDA. If there is anything listed as "other action", click that link and review the document as well. In the case that an FDA-483 or other action document is listed, be sure to ask the 503B for their response to the FDA and for documentation that they've implemented a plan of correction. PLEASE NOTE nearly every single 503B has had a letter issued. This is not uncommon. The important things to consider are findings and their corrective actions.
***SPECIAL NOTE ABOUT COST*** You should never solely base your decision about drug purchasing on cost. Patient safety and product quality should be your top motivators when considering who to purchase from. However, if all other criteria appear to be equal between two companies, purchase the item(s) with the better price... WITH CAUTION. If you notice a slight price difference of cents to a few dollars, this is normal fluctuation in market pricing between two competing companies. However, if you compare pricing between like compounders (only compare 503B against other 503B, or 503A against other 503A), and one has a drastically lower price, ask why. It's entirely possible that the company with the lower price is positioning themselves to offer competitive pricing. But if you're getting what appears to be an amazing deal, make sure it's not at your expense in the long run. 1. Is the product short dated? Ask what the BUD is and what the anticipated shelf life of the drug will be once it's on your shelf. 2. Is it possible that they're cutting corners somewhere to reduce cost? 503B products are often more expensive than 503A products because of the additional testing and qualities measures that go into the manufacturing process. If a 503B is offering a product at a price that's too good to be true, double check to make sure you've gotten those sterility and stability test results for this product. 3. Ask your rep how they're able to beat everyone else's price.
Will JDJ Consulting tell me who I can or can't use? No. JDJ Consulting will never give approval or denial to your choice of compounding pharmacy, whether it be a 503A or 503B. We have visited some facilities in the US and will make recommendations for which facilities we feel are the best fit for our clients. However, it is ultimately up to you to decide which compounders you should order from. During our visits to 503A and 503B facilities, we use the same regulatory metrics that FDA auditors use, although our visits are much shorter and less involved. We ask questions about quality testing, sterility, the compounding process, their workflows, areas of risk, and customer service. During these visits, we ask that compounders be able to respond reasonably to any FDA citations and explain how they have corrected those findings.