Setting up effective, compliant investigational drug pharmacies means reviewing Food and Drug Administration (FDA)  requirements and applicable state boards of pharmacy.  Depending on the regulatory body reviewing the pharmacy, different parameters may need to be met. It is also important to have a well-developed process in place to ensure the accuracy and precision of drug products. 

What Do State Boards Look for?

The state board of pharmacy tends to be associated with the practice of pharmacy, which may be specific based on each state.  State boards deal with pharmacies at an individual level, and aim to ensure that facilities meet the requirements of the state board, and are appropriately registered and staffed.

What Does the FDA Look for?

In contrast to state boards, the FDA takes a more exhaustive approach.  The FDA generally looks for the compounding of marketed and unmarketed products which are able to meet the same accurate and precise measures every time.  In order to meet this standard, investigational pharmacies must focus on developing several processes.

What Should Companies Focus on?

Setting up a quality system

In order for companies to make sure that their products are consistent, an effective quality system must first be put into place.  Quality control involves testing and inspecting product components to ensure that they meet approved specifications. All of the different specifications should be met before being put into the quality system so that quality is designed and manufactured into the product itself.  This process is often referred to as “quality by design.”  

When setting up a quality system, one of the common setups that is used is the Deming or Plan-Do-Check-Act (PDCA) cycle.  This cycle allows companies to produce precise, accurate results every time.

Corrective and preventative actions

The FDA will typically look at seven major components of quality systems when measuring accuracy and precision.  They are mainly looking to make sure that there is a process in place to correct potential problems, and generate preventative actions.

A corrective action involves addressing immediate problems and taking action to ensure that they are dealt with.  However, companies need to focus on more than this and take preventative action to ensure that future problems do not arise.  In order to take preventative action, companies must often perform a root cause analysis to evaluate why and how a given problem happened in the first place.  

Production and process controls

For production and process controls, the FDA will generally review process design, process qualification and continued process verification or validation.  

Process design is involved at stage one, and refers to the commercial manufacturing process.  To meet FDA standards, companies must demonstrate that their manufacturing process is appropriately designed.  The manufacturing design is evaluated on the basis of how well it can reproduce commercially manufactured products.  Next, companies must demonstrate ongoing assurance during production to ensure that the process remains controlled.

The process of validation requires companies to detect sources of variation in their products.  Further, companies must understand how this variation might impact the process and product attributes.  Companies then must control the manufacturing process so that variation is reduced. In order to do this, a list of quality attributes must be created to refer to.  

Anti-contamination measures

Another factor that pharmacies must consider is making sure that there is no risk of contamination.  This means that the suppliers in the supply chain are trusted sources, and that frequent sampling and testing is performed.  Approved procedures must also be written to ensure that, for instance, the containers being used do not react with the drug product.  Light-sensitive products must be accounted for, and placed in the correct containers. It can also be helpful to maintain an input log tracking where the requirements for the products are regarding material controls.  

SOPs (Standard Operating Procedures)

Investigational pharmacies must also ensure that they set up SOPs relating to the storage, return, and destruction of products.  If a sponsor decides not to keep an investigational drug product, there must be a SOP in place. This SOP will determine how long the product is going to be kept in the pharmacy, and when and how it will be destroyed.  

Staying Informed

Companies must remain aware of the differing regulations provided by the FDA and state boards in order to ensure compliance when setting up investigational pharmacies.  These requirements are also subject to frequent change. This means that it is essential for companies to stay informed on new laws and regulations being issued by these regulatory bodies.  

If you have any other questions about how you can set up an investigational drug pharmacy or how current regulations affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.

Blog Disclaimer

The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.