Over the past two years, COVID-19 wreaked havoc throughout the world. The healthcare system and workforce have been terribly strained ever since. Hospitals are still experiencing shortages of pharmacy technicians, and don’t forget the ongoing shortages of medications and products that patients need.
More and more hospitals and pharmacies today are turning to outsourced 503B compounding facilities to address shortages in staffing, improve efficiency and productivity, and alleviate the impact of the ongoing drug supply disruptions.
503B outsourcing facilities have produced and provided Compounded Sterile Preparations (CSPs) in bulk quantities under the Drug Quality and Security Act (DQSA) since 2013. These registered 503B outsourcers must comply with state and federal guidelines and meet strict Current Good Manufacturing Process (cGMP) standards. They’re also routinely inspected by the FDA.
503Bs can help enhance the pharmacy supply chain. However, it’s important to choose wisely and ask a lot of questions when considering which one is right for you. Here are some of the benefits of using a 503B:
- As a requirement by the FDA, medications that are produced by 503B outsourcing facilities must follow strict testing standards for sterility, potency, and endotoxins. Since hospital pharmacies aren’t licensed by the FDA, 503B facilities are held to higher standards of safety and quality by the regulations set by the administration.
- 503B outsourcers have the ability to produce higher volumes, often through automation, which provides major cost savings to 503B customers and healthcare partners. This also saves time and costs associated with compounding, documenting, and wasting or scrapping products.
- By partnering with a 503B outsourcer, you’ll have the ability to easier access the medication you need. For example, some 503B outsourcing facilities are able to produce commercially available drugs in a ready-to-use format. They are also able to produce drugs that are on the FDA Drug Shortage list from API. And if a drug product is withdrawn by a commercial manufacturer for reasons unrelated to safety or efficacy, 503B outsourcers will help out by producing that drug until it’s commercially accessible again.
- Did you know that because 503B outsourcing facilities are required to be registered with the FDA, they have to comply with a set of requirements dictated by Current Good Manufacturing Practices (cGMP)? These requirements include providing for systems assuring proper design and monitoring; assuring the strength, quality and purity of drug products; obtaining quality raw materials and detecting /investigating product quality deviations; and maintaining reliable testing labs.
- As a pharmacy leader, you should review your compounded sterile product (CSP) needs. You should also select more than one 503B partner to meet your product and volume demands. This can help mitigate reliance on just one supplier, especially if they were to encounter a disruption in service. It also allows for more competitive pricing and helps advance patient care.
Once you partner with 503B suppliers and have been with them for a short while, conduct regular business reviews with them. Go over sales information and volume. Are they meeting commitments and maintaining high service levels? Remember: You can also work with your 503B partners to refine medication lists or work together to develop new product formulations to help cut costs, thus offering higher patient benefits.
503B outsourcers are a valuable asset to healthcare organizations. With stricter regulations, there’s no question they can provide healthcare organizations like yours with a wide range of options. Because patient safety and cost-effective care has never been more noted, carefully gauge your individual needs before deciding on a 503B partner.
A Member-Owned Company Serving Independent Pharmacies
PBA Health is dedicated to helping independent pharmacies reach their full potential on the buy-side of their business. Founded and owned by pharmacists, PBA Health serves independent pharmacies with group purchasing services, wholesaler contract negotiations, proprietary purchasing tools, and more.
An HDA member, PBA Health operates its own NABP-accredited secondary wholesaler with more than 6,000 SKUs, including brands, generics, narcotics CII-CV, cold-storage products, and over-the-counter (OTC) products — offering the lowest prices in the secondary market.
