We have been accredited by Pharmacy Compounding Accreditation
Board (PCAB) and United Credentialing and Accreditation Program (UCAP), both within three months! That was a real chore! What does Accreditation mean and why is it important?
To start, I will give you the Mission of PCAB:
- To organize and carryout a comprehensive program of voluntary accreditation in the practice of pharmacy compounding.
promote, develop and maintain principles, policies and standards for
the practice of pharmacy compounding in the public interest and to apply
these in the accreditation of pharmacies that offer pharmacy
compounding to improve the quality and safety of pharmacy compounding
provided to the general public.
- To offer to the public and prescribers a way to identify the pharmacies that satisfy accreditation criteria.
provide a public forum for information on the practice of pharmacy
compounding, and to educate the public on the importance of pharmacy
The FDA has guidelines (USP <795>) for compounding pharmacies to ensure the products made are done in a way that protect the safety of the public. The FDA can and has inspected pharmacies, however, individual State Boards of Pharmacy regulate compounding pharmacies within their state jurisdiction. The State Boards of Pharmacy usually inspect their pharmacies once a year.
Accreditation comes from outside people specialized in the task of credentialing and accreditation. They come into the pharmacy and inspect every aspect of your business. They inspect all the documentation required in USP <795>, the compounding processes, staff safety while compounding, how we fill prescriptions, how the pharmacist verifies prescriptions and formulas for products needed compounding that day, how we counsel patients, who we receive bulk chemicals from, customer service operations, etc. They check off what the USP <795> requires of a compounding pharmacy, which is a lot of procedures and documentations. We had two of these within three months!
The accreditation is a big deal, because it lets us know and especially the public and clinicians we operate our pharmacy according to the FDA guidelines. This ensures we have processes in place to protect the public's safety and ensures everyone that we provide quality products. Our integrity is at stake and we strive to provide a product with the highest quality with the best customer service. Now we have a seal from two accreditation services that lets the public know that! How do you know your compounding pharmacy is following the strict guidelines, which provides you assurance they are doing things the way the FDA requires to protect your safety and ensure the best quality product? Accreditation! If there is no accreditation, there is no guarantee they are following the proper procedures and processes to compound your product.
As a side note, you would not believe how many thousands of dollars it cost the pharmacy to have a third party entity come in and inspect us and provide the credentialing. We are crazy enough to have it done twice!
C. Craig Wells, RPh, Pharmacist in Charge