What are 503B Outsourcing Facilities?

What are 503B Outsourcing Facilities?

503B outsourcing facilities are registered with the FDA to manufacture compounded medications in large bulk volumes to ship for office use and can also dispense patient-specific prescriptions. Most compounding pharmacies that we’re familiar with are 503As, which means they can make small batches, patient-specific only. If you’re in a field where you’re doing anything office use (administering office injections, IV’s, things of that nature; or looking for the best price point), then working with a 503B is beneficial. 503Bs are beholden to the higher standards of current Good Manufacturing Practices (cGMP) just like Big Pharma. They have more stringent testing for potency and sterility, but medications and products can also be made in large batches, so they become more cost effective. Most of the cost involved with medications is in the labor and testing. Based on economies of scale the more medications the pharmacy can make the more cost effective each unit becomes.

Here are some examples of why it’s important to build a relationship with a 503B outsourcing facility when you are practicing this type of medicine. Establishing a relationship with a licensed compounding pharmacy is important for physicians who need access to hormones, PDE-5 inhibitors, penile injections, gonadotropins, and other specialty medications often prescribed for testosterone therapy in sexual medicine. The reason for this is that some of these medications aren’t available commercially, are often on back order, or most importantly, are very expensive. For example, as most of us know, PDE-5 inhibitors like Viagra run anywhere between $65 to $73 per 100 mg tablet, whereas a compounded generic can cost between $4 and $6, roughly 5-10% of the cost.

503B outsourcing facilities are registered with the FDA to manufacture custom injectable medications in large quantities to ship directly to clinics and hospitals for office use. That’s something that regular compounders cannot do. 503Bs use raw materials sourced from FDA-approved suppliers, the same suppliers that commercial manufacturers use. 503Bs can manufacture large quantities to offer catalog medications at a very low price. Very few 503B outsourcing facilities specialize in testosterone and ED medications. A lot of them focus on the whole purpose of a 503B to fill a niche that commercial manufacturers don’t fill, primarily the IV bags used in hospitals.

At least one pharmacy is licensed in all 50 states to provide both patient-specific and bulk medications for clinic administration, which is important especially if you have multiple locations where you are treating patients across state lines. Of course, adhering to cGMP and USP guidelines is important to always guarantee that the product is sterile and potent for the duration of the shelf life if it’s properly stored. Being able to work with a compounding pharmacy often results in better patient care, because the compounding pharmacies tend to bring back the triad of care that’s missing with the communication between the pharmacist, the patient, and the doctor. Since these medications are often customized, compounding pharmacists have a good relationship with the physicians and communicate very well with them. In turn, they also communicate very well with the patient. That’s something that often gets lost in retail pharmacies.

Here are some of the medications commonly prescribed by physicians and made at a 503B facility within the integrative sexual medicine realm: Injectable testosterone, transdermal testosterone, and other hormones as well; subdermal testosterone pellets, as well as other hormones like progesterone and estradiol; lyophilized gonadotropins for fertility or as an adjunct to testosterone therapy; aromatase inhibitors for estrogen control and SERMS, which are another hormonal agent to stimulate the hypothalamus-pituitary axis. Then into the ED and sexual dysfunction medications; PDE-5 inhibitors, Tri-Mix, etc. Several compounding pharmacies have a whole line of ICI medications; Bi-Mix, Tri-Mix, Quad-Mix and some formulas in between.

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