503B COMPOUNDING

Premier provides safe, effective, and innovative solutions to help our customers navigate the challenges of today’s medication supply chain
503B compounding pharmacy, 503B compounding service, sterile 503B compounding service, 503B compounding, 503B compounding injectables

A NEW STERILE COMPOUNDING PATHWAY

On November 27, 2013, the Drug Quality and Security Act (DQSA) was signed into law, which increases FDA oversight of some types of compounding. The law created the outsourcing facility or 503B compounding pharmacy under a new section titled 503B of the Food, Drug & Cosmetic (FD&C) Act. This designation requires compliance with cGMP and enhanced reporting.

One of the main advantages of a 503B compounding pharmacy is the ability to make preparations in bulk without patient specific prescriptions. This helps hospitals and healthcare systems that are struggling with drug shortages, price gouging, and sourcing difficult to find medications. In fact, the FDA has encouraged hospitals and medical centers alike to use a 503B compounding service to meet these specific needs.

The compounding pharmacy industry is still in the midst of transformation, but the good news is that quality and compliance are beginning to see eye to eye with the large pharmaceutical companies such as Pfizer, Merck, etc. At Premier Pharmacy Labs, the change is fully embraced, especially with our push to automate the 503B compounding injectables space. Premier Pharmacy Labs is proud to be part of the new 503B compounding designation.

503B COMPOUNDING FOCUS

Sterile, non-sterile and admixture 503B compounding services performed in a quality controlled automated environment. We can provide nearly any compound in any dosage form, but the list below is a sampling of our product set:

  • Sterile Injectables
  • Oral formulations
  • Topical formulations
  • Ophthalmology formulations
  • Urology formulations
  • Nasal Sprays
  • IV bags

WHY PREMIER

  • 503B compounding service for hospital, office, or research
  • Competitive pricing
  • Availability of Product
  • Rapid turnaround
  • GMP QC and Compliance
  • In-house testing
  • Nationwide shipping

OUR CUSTOMERS

  • Hospitals
  • Medical Centers
  • VA Health Systems
  • Surgical Centers
  • Universities
  • Specialty Clinics
  • Research Institutions

 

 

EASY ONLINE ORDERING

Convenient online ordering and reordering with the click of a button. See order history, invoicing and track shipments

REGISTER NOW

fdaalogo

The FDA is encouraging all hospitals, surgical centers, universities and ophthalmologists to utilize the services of a registered and inspected 503B outsourcing facility to meet their admixing, repackaging and compounding needs. As the laws and regulations expand, only 503B outsourcing facilities like Premier Pharmacy Labs will be able to fulfill your needs. See Full FDA Statement