Before the era of mass production, pharmacies created medications for patients from scratch, be it for body pain or more severe illnesses. That hasn't changed even while over-the-counter drugs became available, as many people have unique health needs. Pharmacies continue the tradition, though under a different term known as compounding pharmacies.
Initially, compounding pharmacies could only make bespoke medication in limited quantities. However when the Drug Quality and Security Act (DQSA) became law in 2013, these facilities were split in two. The first is the conventional compounding pharmacy known as a 503A, as the other is a compounding pharmacy that may produce bespoke meds in bulk, known as a 503B.
Section 503B
The term '503B' refers back to the provision put into the government Food, Drug, and Cosmetic (FD&C) Act by the DQSA. To put it simply, it allows a compounding pharmacy to become categorized being an outsourcing facility. Whether it meets federal standards and submits to oversight, a 503B outsourcing facility like the one at Fagron Sterile and others can mass-produce meds and medical supplies.
Anything that a 503B outsourcing service makes doesn't have to find approval from the Fda (FDA). But to become granted his privilege, the facility must meet all the requirements from three sections of the FD&C Act, specifically:
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- Section 502(f)(1) – labeling drugs with directions for use, assuming they're already well-known to ordinary consumers.
- Section 505 – submitting complete reports of the drug's effectiveness and safety to the FDA, including 505(b)(1), 505(b)(2), and 505(j).
- Section 582 – informing the FDA and other partners of counterfeit or illegally diverted products within their possession within 24 hours of finding out.
Submitting to monitoring by government agencies is optional for 503B outsourcing facilities, however the FDA offers incentives to those that do. Many of these include additional exemptions, such as requirements for getting approval for newly formulated drugs.
Too Much Leeway?
It isn't unusual to consider this much leeway for 503B outsourcing facilities can be a reason to be concerned. In the end, why would such facilities seem to be susceptible to less scrutiny than traditional drug manufacturers? However, that's not the situation for many reasons.
First, it's essential to understand the reason the DQSA became law. It had been introduced following a fungal meningitis outbreak in 2012 that killed around 100 and afflicted hundreds more. In this instance, the outbreak originated from a compounding facility, which federal and state regulators couldn't monitor effectively due to the insufficient a concrete framework.
Second, the relative abundance of exemptions doesn't mean that 503B outsourcing services are exempted from the law. The FDA strictly requires these to create meds and medical supplies as per Current Good Manufacturing Practices (CGMP) outlined in 21 CFR 210 and 211. These types of services adhere to a lot more CGMPs than you may think, lest they risk another deadly plague.
Lastly, and that has arguably put these facilities within the limelight lately, would be that the U.S. healthcare product is under immense pressure because of the pandemic. Recent drug and medical supply shortages have but stopped the treatment of many illnesses, with the majority of the availability visiting the country's COVID response.
As drug manufacturers find it difficult to meet demand, hospitals and clinics turn to 503B outsourcing facilities to enhance their supplies. The FDA can allow them to produce certain drugs, provided they're on the FDA's drug shortage list and is not a copy of the FDA-approved drug. Their timely assist in pandemics along with other health crises can save countless lives.
Coming Full Circle
The existence of compounding pharmacies, not to mention 503B outsourcing services, exemplifies how history originates full circle. The decades-old practice of making medication on the spot slowly returns towards the modern healthcare scene. And based on recent statistics, this type of trend is not likely to abate in the near future.
Market analysts project that the 503B compounding pharmacy market will grow by 7.3% between 2023 and 2028, breaching the USD$1.5 billion mark. The FDA and also the Centers for Disease Control and Prevention cite the drug shortage and the rise in the elderly population as the main drivers for the market growth. New medical approvals are also expected to skyrocket over this period.
More importantly, technological advances will complement traditional compounding practices. The facilities curently have access to state-of-the-art equipment like automated assembly lines and ISO-compliant cleanrooms. There's even a lot of talk about blockchain's role in improving the quality of medication and medical supplies.
Conclusion
As an ageless adage goes: The greater things change, the greater they stay. Pharmacies may continue to dispense manufactured medication, but the tradition of making bespoke meds remains alive among their compounding counterparts. The amount of leeway what the law states grants them shouldn't be an issue, because they strive to be as compliant as licensed drug manufacturers.
