According to the USA Food and Drug Administration, a 503B outsourcing facility is a premise found in one geographic location that’s set aside for compounding sterile drugs. The facility has to meet the following three requirements for it to be considered an outsourcing facility:
- It has to be registered as an outsourcing facility
- It has to comply with all requirements of section 503B in its operations
- It has to deal with compounding sterile drugs
Compounding sterile drugs is manufacturing medication in an environment that’s free of infectious microorganisms such as bacteria and viruses. Compounding is done to create medication to suit the needs of a particular patient. Sites like Fagron Sterile explains more about sterile compounding.
However, this article will look into the history of sterile compounding and the benefits of working with a 503B outsourcing facility. Keep reading to learn more.
History of Sterile Compounding
The idea of a 503B outsourcing facility wasn’t developed until 2013. Before this, hospitals compounded their drugs in a 503A pharmacy or in-house. In 2012, a tragic incident happened wherein 64 patients died, and 750 more were injured from using medication that was sourced from a 503-pharmacy called New England Compounding Centre.
Upon investigation, experts found that the medicines were contaminated with Aspergillus fumigatus, which led to the victims contracting fungal infections, including meningitis. Following that event, the state and the federal government started scrutinizing the quality and safety control of traditional compounding.
The government finally passed a law under The Drug Quality and Security Act that required the pharmaceutical sector to have 503A pharmacies and 503 B outsourcing facilities. The 503B outsourcing facilities were mandated to ensure the safety and security of compounded drugs, and it has done so since 2013.
Here are reasons you should work with a 503B outsourcing facility:
1. Guarantees Safety And Quality Control
All medication manufactured by 503B outsourcing facilities must meet the USA Food and Drugs Association requirement. These drugs are tested for endotoxins, potency, and sterility to ensure safety and quality before they can be released for consumption.
As such, working with a 503B facility ensures that you’re giving your patients safe and quality medication. With the medication meeting all FDA standards, you don’t have to worry about its quality, reducing the burden of work on your end.
Other than safety and quality, 503B outsourcing facilities provide crucial information such as
- The expiration date of the medication
- Product serial number
- History of a transaction or transactional statements
2. Reduces Liability
As mentioned before, all 503B outsourcing facilities must comply with FDA regulations in all their operations. The 503A pharmacies are regulated by state boards and must comply with the United States Pharmacopeial convention.
The FDA visits 503A facilities that employ questionable practices. If the products are contaminated, and you dispense them to your patients, you risk being sued for issuing bad medication.
You want to avoid such liabilities. Unfortunately, the tools and technologies to ascertain safety and quality control are expensive, and so is the process. Therefore, outsourcing the task to a reliable facility would be the best method. That’s what 503B does. It ensures all your medications are produced in accordance with FDA regulations.
3. Wider Outreach
Medication from 503A facilities is only sold within some given states. This controls the spread of any potential liabilities but limits your market outreach.
However, working with 503B outsourcing facilities means that all medication is produced according to FDA regulations to ensure safety and quality. Products from these facilities are approved to be sold to states across the country. This allows for a wider market.
4. Save On Cost
The 503 B outsourcing facilities produce sterile compounded medication in bulk. This helps to reduce the cost of compounding, documenting, and producing the products. Hence, this is sold at a lower price to health care customers.
Additionally, some of the established 503B outsourcers have automated the compounding process, which has since been a cost-saving measure of production.
The 503B outsourcing facilities are known for producing customized medication. There are several reasons a patient would need customized medicines. For example, if the patient is allergic to a certain ingredient in the commercially available medication, they may need a version of the drug which is free of the allergic compound. You can get such drugs from 503B outsourcers.
Other than that, the facilities are allowed to produce other forms of medicines, for example, liquid medicine for kids who don’t have the reflex to swallow pills. The facility ensures that the liquid medication is as effective as the pill.
Therefore, if you’re looking to meet the needs of a diverse market, it helps when you source all your medicines from a registered 503B outsourcing facility.
Wrapping It Up
A 503B outsourcing facility ensures safety and quality in all their medicines. Additionally, all their operations, including sterile compounding, must adhere to FDA regulations. This, therefore, helps to ease compliance on your end. It also favors you by opening you up to a wider customer base. Other than that, because 503B outsourcers produce their medicines in bulk, their products are usually more affordable, which helps you save on cost. Last but not least, dealing with a 503B facility gives you access to customized medication. Therefore, if you’ve been looking for a reason to work with 503B outsourcers, these five benefits should be enough to convince you.