The fallout from the NECC-Meningitis compounding tragedy has prompted New Jersey lawmakers to require New Jersey compound pharmacies to be “accredited.” On October 15, 2012, New Jersey Assemblyman, Sean Kean, introduced legislation (A3395) that would require compounding pharmacies in New Jersey to be accredited by the Pharmacy Compounding Accreditation Board (PCAB). The Bill expressly applies not only to in-state compounders, but also to out-of-state pharmacies that ship compounds into New Jersey. Once signed into law, no compounding pharmacy doing business in New Jersey will be permitted to continue its compound pharmacy operations without PCAB accreditation.
Other States are expected to follow New Jersey’s lead. Your compound pharmacy should consider PCAB accreditation immediately.
The Bill requires compounding pharmacies to meet nationally-accepted quality assurance, quality control and quality improvement standards required for PCAB accreditation. PCAB standards have been developed by a committee of compounding pharmacists, academics and experts. Examples of PCAB’s standards include requirements that accredited pharmacies:
- Use only high-quality chemicals and equipment
- Ensure that their compounding pharmacists and pharmacy technicians receive regular, specialized training
- Evaluate the quality of their preparations through a system of testing
- Have an effective recall mechanism that allows them to identify who received a particular compound
Frier Levitt assists compounders with achieving PCAB accreditation.
Things to Know Regarding PCAB Accreditation
The Costs Associated with PCAB Accreditation:
- There is a one-time initial fee for submitting an application (presently $250). The fee is not refundable if the pharmacy is not granted accreditation.
- Each pharmacy also pays an annual fee, and the first year’s fee is due when the pharmacy completes the application and indicates it is ready for accreditation. The fees depend on the annual volume of compounding performed in that pharmacy. Accredited pharmacies pay an annual fee based on prescription volume.
- Finally, compounders must also pay the actual expenses of the on-site surveyor(s) which typically include travel, meals and hotel expenses.
The PCAB Accreditation Process and Timeframe:
While the PCAB application itself is relatively straightforward, many of the Standard Operating Procedures (SOPs) required for PCAB accreditation can take a substantial amount of time to develop and implement. Thus, we strongly recommend you have the assistance of knowledgeable legal counsel to help you navigate the waters of the application and accreditation process.
A PCAB application may be completed online. Importantly, SOPs are not submitted with the application, but they must be available for the surveyor’s review during the initial on-site survey (discussed below).
Once the online application is submitted, PCAB runs a license check which takes about a week for PCAB to get the results back.
When PCAB receives the results of the license check, PCAB schedules the initial on-site survey. PCAB is presently running about 2 – 3 months out with its surveys. Notably, in our recent discussions with PCAB officials, Frier Levitt has been advised that this timeframe is likely to increase as more and more New Jersey compounders seek PCAB accreditation in light of NECC-meningitis tragedy. It’s important that you begin the PCAB accreditation process right away.
The initial on-site survey takes approximately 1 day. Thereafter, the pharmacy receives a post-survey report within approximately 5 – 7 business days. If the pharmacy is compliant, the post-survey report is forwarded to PCAB’s accreditation committee for approval. If the pharmacy is not compliant, the pharmacy is advised of any issues and is given 120 days to take corrective action and to submit documentation proving that the issue(s) has been corrected. Even the most organized compound pharmacies frequently have issues that need to be corrected at this stage.
For more information on the New Jersey Bill, the PCAB accreditation process, and how Frier Levitt can assist your compound pharmacy in achieving PCAB accreditation, contact Frier Levitt.