What is a 503B outsourcing facility?

When we reach out to a clinic or hospital to introduce ourselves, we describe ourselves as a 503B outsourcing facility. And we have found that quite often, there is an awkward silence or an exclamation of “What is that?” We did not realize that “503B” is still a new concept. Therefore, we thought it helpful to layout the concepts of what a 503B outsourcing facility is, its benefits, and why Compound Preferred is the preferred choice.

What does 503B outsourcing mean?

The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that may manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use only. These facilities can use larger batches to lower their manufacturing costs, passing the savings onto consumers.

 Do these facilities compound medications?

Yes, we compound medications. Compounding pharmacies are beneficial when the one-size-fits-all approach does not work. Compounding provides access to drugs for patients who may not be able to use commercially available formulations due to dosing requirements, allergies, or rare diseases. But that is not the only capability we have. 

We can also cover drug shortages, making medications available when large manufacturers cannot accommodate supply. We can also create new medications custom-designed to serve unique needs. 

Why wouldn’t a clinic or hospital use a 503A pharmacy over a 503B outsourcing facility for medication needs?

 Indeed, 503A is often considered more of a traditional compounding pharmacy. They make medications that are patient-specific and can only be produced in small batches. And they typically sell directly to the patient. Because medications can only be formed in small batches, it means they are more expensive. This cost is often passed onto the patient. 

Also, their products have much less quality control requirements. They do not need to follow Current Good Manufacturing Practices (cGMP). Their potency and stability are not tested and can vary.

503B pharmacies – or outsourcing facilities – produce large batches of medication for use in healthcare facilities, surgery centers, and physicians’ offices. 503B pharmacies were signed into law (The Drug Quality and Security Act (DQSA)) in 2013 to bridge the gap between small compounding pharmacies for individual needs and mass-produced medications from the manufacture. 

 Regulations are stricter for 503Bs. In addition to the manufacturing and compounding of specific medications, even the processes of packing, labeling, storing, and shipping specific medications is all highly regulated. And thorough tests must be done and logged at every stage. Before a medication can ever be produced, process and product validations must occur, ensuring that each batch of medication is of the highest quality. Furthermore, all testing methods must be validated before any active testing to assure compliance with USP testing standards. A product list must be provided biannually to the FDA. They are steady and stable in standard operating procedures, regulatory compliance, and raw material resources. 

503B compounding pharmacies are entirely able to meet the supply demands of hospitals, healthcare systems, and ambulatory surgery centers and put patient safety and medications’ effectiveness first.

Why choose Compound Preferred?

 Since we are small, we can get medications out with quick turnaround, guaranteeing prompt delivery. 

 By partnering with Compound Preferred, we can not only save clinics money, but we can also diminish the amount of waste. With unit dosing, we can aliquot medications so that every milliliter is being used. This saves both the clinic and patient money. 

Not only do we offer aliquoting, but our agile processes also allow for custom solutions – allowing the physician to customize treatment for their patients. 

We are highly specialized, offering quick turn custom solutions focused on quality and perfect in price.

Filling the 503A Gap

While 503A compounding pharmacies fulfill a vital need for patient-specific compounded products, 503B outsourcing facilities fulfill another need to the medical community. 503B outsourcing facilities

503B Outsourcing Facility Myths and Facts

503B outsourcing facilities provide in- office-use medications to the medical community. Regulated by the FDA and state entities, 503B facilities are fairly new to the