How to Successfully Earn a PCAB Accreditation for Pharmacy Compounding

It was back in October 2012 when drug compounding made all the wrong kinds of headlines. They were convicted by the U.S health officials for having injected patients with products that caused them to contract and die from fungal meningitis. The headlines took a toll on the pharmacy compounding industry and a lot of professional reputation and dollars went down the drain.

However, because of the investigations from the U.S food and drug administration and state, it became evident that it was the NECC personnel who were not complying with the laws that were regulated by the pharmacy for compounding. It was the result of their non-adherence that the best practices of the drug compound industry as harmed, in terms of sterility.

It is because of this huge misunderstanding that a lot of people are still harboring misgivings about the concept of compounding pharmacies. It has therefore become very necessary to assure the highest standard of student pharmacists, pharmacists and pharmacy technicians in order to restore people’s faith and trust in compounding. It is also an excellent way to show the world as well as your colleagues in order to earn a reputable drug compounding accreditation.

What Is PCAB Accreditation?

The Pharmacy Compounding Accreditation Board has reviewed and certified facilities, personnel and procedures in more than a 100 American compounding pharmacies since 2006. It draws funding and expertise from the following among others:

• American College of Apothecaries
• American Pharmacists Association
• International Academy of Compounding Pharmacists
• United States Pharmacopeia
• National Association of Boards of Pharmacy

Characteristics of PCAB Accredited Pharmacies

The PCAB Accreditation indicates the staff that is involved in compounding to have ongoing and proper training, in terms of preparing customized doses of medication for the patients. The pharmacy must use only standard and high-quality active pharmaceutical ingredients and inactive materials. The compounding procedures must also be fully documented and must be carried out only after conformance with the established formulas.

It must be known that Veteran Affairs medical centers can only contract with the PCAB accredited pharmacies.

PCAB accredits non-sterile and sterile drug compounding practices, but it does not vouch for the pharmacies outside the United States or the nuclear pharmacy practices.

NECC was not accredited by the PCAB.

It Starts With the Right People

The pharmacies that are PCAB accredited by the board must demonstrate the fact that everyone who is assigned and affiliated with the concept of compounding must be competent to carry out their assigned duties with precision. This is applicable to the staff pharmacists, supervising pharmacists and the student pharmacies who are assigned with compounding duties and pharmacy technicians.

It is very important for them to show that the staff holds all the relevant certifications, licenses, credentials and all the registrations. It is a must for all the compounding technicians to be certified in order to practice.

The Equipment, Standard and Documentation

It is also important for the pharmacy personnel to document a compliance with USP 795 non-sterile compounding and the USP sterile compounding standards. What this means is that, it is necessary for the pharmacy to be able to produce the standard operating procedures on paper and keep the records that actually match dosages with the individual patients.

It is also important for a pharmacy to have regular and updated logs of when and how the stock is rotated and the equipment is calibrated and cleaned, and the materials are tested for purity and quality. The pharmacies that seek PCAB accreditation must also have the proof of their materials meeting the standards of National Formulary and USP and all their data sheets are updated.

Annual Fees Required

The PCAB accreditation is primarily dependent on the results of on-site inspections, during which the reviewers have to confirm the qualification of the personnel, check facility and equipment and also ensure the accuracy of the documents and the records. It is up to the pharmacies to pay the entire costs related to the inspections. They are also required to pay a one-time application fee, which is based on the compounding volume.

This is all that you need to know about PCAB accreditation and specialty pharmacy accreditation. It is always a big step forward when it comes to specialty pharmacy and staff training. Join with the trusted and never risk your health again!