Compounding pharmacies provide a necessary service to many patients who would otherwise be unable to get proper treatment. However, they often operate in a legal gray area, and there have been cases when that caused loss of life. In 2012, the New England Compounding Center made headlines because one of their products caused patients to contract fungal meningitis. There were 793 infected patients, out of which 64 died.
Incidents like this clearly show that obtaining proper compounding pharmacy accreditation is not only beneficial but should also be necessary. Any type of pharmacy should stick to strict rules and regulations to ensure that the medications they produce are safe. Let’s have a closer look at the process of getting a compounding pharmacy accreditation and why that’s considered good practice:
The Founding of the Pharmacy Compounding Accreditation Board (PCAB)
In order to prevent further accidents related to compounding medications, eight pharmacy organizations joined forces to create a system of standards for compounding pharmacies. The PCAB is the result of those efforts. It’s a way for compounding pharmacies to obtain accreditation that will show their patients that they’re maintaining the required quality of their compounds. However, perhaps the more critical function of PCAB is providing a quality testing framework that impacts the entire system of standards for compounding pharmacies.
Benefits of PCAB Accreditation
Patients who are concerned about the safety of compounds they use can rest assured knowing that the PCAB Accreditation means the compounding pharmacy is adhering to stringent standards that ensure quality and safety. By creating this accreditation, the PCAB is aiming to serve the public good by improving the practices of pharmacies and improving the conditions for patients and prescribers. Its significant contribution lies in organizing and carrying out the program of voluntary accreditation that compounding pharmacies should stick to in order to improve their quality and safety assurance processes.
The PCAB has another critical mission, and that is education. Considering the fact that the public often highlights the cases of use of hazardous compounds, it’s important to be informative and show the general public that compounds can be completely safe. For many patients they are the only choice for treatment — so the development of the accreditation is an extremely positive change for the pharmacy compounding industry.
State Regulations and Compounding Pharmacy Regulation
Compounding pharmacies do face state regulation, but it is focused much more on liability issues than the actual safety oversight process. It is why pharmacies have been left to their own devices when it comes to quality assurance. They’re expected to uphold ethical obligations, ensure their products are safe and keep their facilities operating following highest industry standards.
Compounding pharmacies do so with the help of several organizations that can help provide both oversight and accreditation. The Pharmacy Compounding Accreditation Board is one of the leading ones, but it isn’t the only one. There are also the International Academy of Compounding Pharmacists (IACP), the Professional Compounding Centers of America (PCCA), and the Accreditation Council for Pharmacy Education, to name a few.
Equipment, Standards, and Documentation Required for Accreditation
With the PCAB Accreditation, it is necessary for the pharmacy to ensure and demonstrate that every single person doing the compounding work is competent to perform their assigned duties. It includes pharmacy technicians and staff pharmacists, as well as students that are assigned compounding duties, and supervising pharmacists. They all require certification before being allowed to do compounding work at an accredited pharmacy. What’s more, all pharmacy personnel needs to be compliant with USP 795 nonsterile compounding, as well as USP 797 sterile compounding standards.
The pharmacies that have or seek PCAB accreditation need to have large logs and records of everything that goes on at the facility. That includes the times of rotating the stock, testing the materials for purity and quality, as well as records of how and when the equipment is being cleaned and then calibrated. Additionally, they need to prove that they don’t use anything other than active pharmaceutical ingredients or APIs for their compounding, which includes any other materials that meet the National Formulary and USP standards. Pharmacies are also required to list all the APIs that they use on product labels, as well as keep records of the analysis and data sheets about the safety of materials that they use.
When it comes to the facility itself, a compounding pharmacy’s cleanrooms are required to meet ISO-8 standards if they want to be fully compliant with USP 797. For pharmacies that compound the drugs that absolutely cannot be allowed to be contaminated is especially essential. Any contagion would pose a considerable risk for the patient’s health. The environment is expected to be completely sterile, and sometimes regular equipment such as compounding aseptic isolators can’t be fully trusted to ensure that.
The annual fees required for the PCAB Accreditation generally cover the costs of inspection and other yearly expenses. It includes a one-time application fee. The charge itself depends on what the results of the on-site inspections are. The reviewers need to go through all the personnel qualification certificates, ensure that the documents and records kept by the pharmacy are accurate, and check the facilities and equipment.
The pharmacy covers the cost of the inspection. That goes both for pharmacies that are applying for the accreditation for the first time as well as for those who are after reaccreditation.
Compounding pharmacies need to ensure that they have the trust of patients and prescribers. One of the ways of doing that is obtaining the PCAB Accreditation which guarantees the safety of the product. Many pharmacies find it to be worth the investment of time and funds, as it is sometimes the only guarantee patients have that they can use the compound safely.
With standard regulatory practices focused more on liability, it is extremely valuable to have a confirmation that the pharmacy is upholding the ethical and quality standards which patients have learned to expect.