A "Consumer First” Mandate: The California Board of Pharmacy’s Perspective on DSCSA
Many pharmacies and hospitals have been focused on March 1,
Q: What’s the scope of laws that dispensers need to monitor?
A: For the most part, a pharmacy is governed by local, state, and federal law, so businesses really need to keep an eye on multiple agencies for regulations.
Q: How has your office prepared for DSCSA?
A: Our office has a number of pharmacist inspectors who are responsible for inspecting licensed premises for compliance with pharmacy laws in California. We’ve added more staff so that we can be on top of the DQSA sterile compounding regulations, and our inspectors have also been working with wholesale distributors and 3PLs on their compliance, too. But now that we’re past the implementation deadlines for dispensers to be compliant with transaction documentation, and since our licensees are subject to federal inspections, we will turn our attention to the pharmacies to aid compliance with the transaction documents components over the coming months.
Q: How do your investigators become educated on a federal law?
A: To get up to speed, my inspectors study the provisions, the measures of compliance and non-compliance, and any guidance from the FDA. When we review the new requirements, we identify how the requirements mesh with state
The next step then is to start conducting inspections during which we educate licensees if they are not familiar with the requirements. Inspectors provide feedback on how the process is working to their teams, and then to our whole group of inspectors. We also will evaluate the need for expanded information to our licensees at this point.
We also bring information to public meetings with the board, discussing how implementation is going. For major new laws, we typically also provide educational alerts in newsletters or “subscriber alert” email blasts. For major changes, such as those in DQSA, we provide presentations at meetings where pharmacists are present as well.
Q: So state and federal authorities may actually conduct joint inspections?
A: It’s not unusual for the FDA to inspect premises in California. They are doing a lot of that in sterile compounding now. And yes, our staff goes in with the FDA, although we both do separate investigations.
The way for us to be most effective is to work together. Otherwise, the federal regulators may find a violation and issue a fine or impose other sanctions, but then the board has to come in and initiate an investigation to take enforcement action against the licensee. This takes more time for the public to benefit from the findings. It’s preferable for us to go in with the federal regulators so that we can start working on our own case immediately if we decide to open and pursue one.
Q: What’s the goal of any investigation like this?
A: Our goal is to be efficient and consistent in our enforcement, but to always focus on the consumer outcome. We want the impact of any findings to reach consumers ASAP. The more we work together with federal authorities, the more we perfect protection for the public.
Q: What are the likely outcomes?
A: Generally because the FDA hasn’t issued a permit that they can revoke, they are most likely to issue an inspection report with findings, and perhaps a warning letter. The DEA often will pursue actions that result in removal of a DEA permit and fine. For areas outside compounding, we can’t predict exactly what the FDA will do under DSCSA.
From the state perspective, many of our licensees are anxious when we enter a pharmacy to do an inspection because they mistakenly believe our goal is to pursue discipline. Actually, we’re committed to helping educate businesses about compliance as our first course of action. We’re looking to secure compliance unless their practices are an extreme departure from requirements.
For example, if we walk into a premise with foreign drugs, outdated medications and fake or no documents, we’re going to initiate an investigation and direct that some actions be taken by the pharmacy immediately. But if it’s a less egregious situation, we have options to decide whether to secure compliance with the law via
Consumer protection first is truly our mandate, and protecting the public will ultimately drive our actions.
The State of California has been a leader in supply chain safety. In response to concerns about illicit activity, their state legislature passed anti-counterfeiting and anti-diversion legislation in 2004. While portions of the legislation were implemented in 2005 and 2006, the law was ultimately pre-empted by DSCSA.