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How Does 503B Compliance Benefit the Public?

Published in: Pharmacy Times

By Mike Wascovich, PharmD, MBA, RPh, Vice President of Field Pharmacy Services, Premier Inc.

As more companies enter this space, expect competition to further lower prices while improving quality.

The Drug Quality and Security Act (DQSA) created a pathway for pharmacy compounders to be registered with the FDA as outsourced 503B compounding facilities.

This effort was largely in response to the outbreak of fungal meningitis among patients who received contaminated preservative-free methylprednisolone acetate steroid injections because of poor quality control at the New England Compounding Center in September 2012. Section 503B of the DQSA aims to establish federal standards for product integrity, quality assurance testing, reporting, and safety when producing large volumes of compounded sterile products (CSPs).

Pharmacies compound millions of sterile and nonsterile drug doses for patients each year, and many are pursuant to a patient-specific prescription order from a physician or other prescriber. However, anticipatory batch compounding is where pharmacies will produce CSPs in advance of a patient-specific order. Although this process can supposedly save money and time for pharmacies, it is not the ideal practice, given new compounding standards and the limits of the drug's beyond-use-date, as well as requirements for batch testing, analysis, and reporting.

This is where the standards come in to help pharmacists with anticipatory batch compounding. 503B outsourcing facilities have streamlined anticipatory batch compounding by making the process much easier, more cost-effective, and safer when producing large-volume CSPs instead of pharmacies trying to do everything themselves. The mission of 503B suppliers is to provide effective and safe compounded drug products that are not otherwise commercially available. 503B suppliers must comply with current good manufacturing practice (cGMP) requirements, pass an FDA inspection according to a risk-based schedule, meet certain other conditions, report adverse events, and provide the FDA with specific information about the products they compound. They also must hold up to scrutiny by many others, including state pharmacy boards, departments of health, the Joint Commission, and other regulatory bodies.

The scale and size of investment required to operate at cGMP requirements is significant and makes it largely impracticable for community and hospital pharmacies to duplicate this operating model. The cGMP requirements reduce variability, which significantly reduces risk to the public. Although requiring such rigor to produce CSPs raises quality, it also makes it quite expensive to operate. But the process is highly repeatable. There are many 503B suppliers operating within the United States, and many serve all 50 states. These suppliers are incredibly efficient at driving down waste and lowering cost, and at the same time, offer more ready-to-use products. This, in turn, translates into an easy-to-understand return on investment calculation for providers. By lowering providers' costs and raising quality, 503B suppliers produce a win-win solution for the public.

Although the advent of 503B compliance has raised standards and is producing great benefits for Americans, it would be impractical for all CSPs to be manufactured at a 503B outsourcing facility. Providers should seek a 503B supplier to assist them with only the truly laborious CSPs to produce. These may include such products as continuous ambulatory delivery device pumps, controlled substances and narcotics, elastomeric pumps, high-risk compounds, and infrequently used medications. 503B suppliers can also assist pharmacists working with active pharmaceutical ingredients (APIs) or nonsterile drugs and can help sterilize the final product. This assistant permits these difficult-to-handle medications to be produced with a high degree of certainty and quality, and at the same time, allows the local pharmacy team bandwidth and time to focus on the patient-specific CSPs that are needed acutely and on a smaller scale.

503B outsourcing facilities benefit the public by producing medications found on the FDA's drug shortage list. By working with APIs and raw materials with a cGMP standard, patients and providers have access to drugs that would otherwise be unavailable. Drug shortages across the United States continue to be a problem, but the impact of these shortages has been negated to some extent by 503B outsourcing facilities. Another tangible benefit of this impact is the vital role that 503B suppliers played in supplying hospitals with shortage medications required to treat critically ill patients with COVID-19 during the peak of the pandemic.


503B compliance has raised the bar on quality and safety for patients and providers alike in the United States. As more companies enter this space, there will be competition to further lower prices while improving quality. The benefit of the DQSA to the public is being realized.

This article ran in Pharmacy Times on May 26, 2021.

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