The Backup Pharmacist-in-Charge: The Growing Importance to Specialty Pharmacy

Licensing requirements across states are becoming more stringent, with some states trending toward having a pharmacist-in-charge (PIC), who is licensed in that particular state for pharmacies seeking a non-resident pharmacy license.

If you have a brick-and-mortar pharmacy in the state your pharmacy serves, it would not be unusual to have multiple pharmacists holding licensure in that state. For the fastest growing sector of the pharmacy model, specialty pharmacy, the model is likely not based on a brick-and-motor presence, but rather one store serving the needs of several states.

That pharmacy would likely have a resident pharmacy license in its home state, and a series of non-resident pharmacy licenses in the states into which it dispenses. Under this model, for a pharmacy located in Tennessee that holds a non-resident pharmacy license in Texas, losing its Texas licensed pharmacist-in-charge may present more of a challenge. Under this model, proper succession planning for your PIC is a must for continuity of business.

While I consider Tennessee my home state, and Texas is my birth state, these states have more in common than marking the geography of my life. Tennessee and Texas are both states that require a PIC who is licensed in that state, regardless of where the pharmacy is located.

While the requirement may appear straightforward, the reality of compliance may present more of a challenge if your pharmacy does not have a succession plan in place in the event of an uncontemplated departure of your state registered PIC. Just as a good pitcher has back-up in a relief pitcher, the PIC should also have a back-up PIC.

In Tennessee, the requirement to have a PIC with an active Tennessee license applies to both resident and non-resident pharmacies dispensing into the state. A pharmacist may become licensed in Tennessee in one of two ways.

The first is by applying for and successfully completing the requirements for licensure in Tennessee including successful completion of the examination requirements, completion of a minimum of 1700 internship hours, completion of the Practitioner Profile Questionnaire, and a criminal background check.

Most of the requirements are included in a checklist on Tennessee form PH — 4022. Depending on the individual pharmacist, there will need to be some lead time built in for exam preparation, and the completion of the application to successfully meet the requirements.

The second way for a pharmacist to become licensed in Tennessee is by reciprocity. The general requirements for reciprocity are found on the Tennessee Board of Pharmacy website on the link entitled, “Instructions for Obtaining a Reciprocal License.”

Generally, the requirements include an application through the National Association of Boards of Pharmacy, a fee, successful completion of the MPJE exam, a criminal background check, and a declaration of citizenship. Tennessee only accepts reciprocal NAPLEX scores from a state that will honor a reciprocal NAPLEX score from Tennessee.

Both resident and non-resident pharmacies must complete Tennessee form PH — 4014 which requires a Tennessee licensed PIC to fill out and attest to certain sections of the application. Form PH-4014 states, “Rule 1140-01-.08(3)(a)(8) requires that you designate a pharmacist in charge who shall be responsible for compliance with the provisions in this section, and who shall hold a current Tennessee pharmacist license.”

In the event the PIC registered to the Tennessee pharmacy license departs, the new designated Tennessee PIC has ten (10) days to complete form PH — 4012 to report the change. If the pharmacy is unable to designate a current Tennessee licensed PIC within 10 days of the change, then the pharmacy must cease dispensing into Tennessee until the requirement is met and the pharmacy license is reinstated. In Tennessee, the 10-day period for reporting the change is the only grace period currently allowed.

The Texas form for a change in PIC states on its face, a “Non-Resident Pharmacist-in-Charge must have a Texas Pharmacist License, see Rule§291.103.” The requirement is self-evident if the pharmacist is practicing within the state.

The Texas requirements for a pharmacist to become licensed in Texas are similar to Tennessee. A pharmacist may either seek licensure through application of initial impression or via reciprocity.

In the event the PIC associated with the pharmacy’s Texas license to dispense departs, the pharmacy must notify the Texas Board of Pharmacy within 10 days of the change. The notification must contain the name of the new pharmacist who will be the replacement.

While the pharmacy must notify Texas within 10 days of the change, a pharmacist seeking Texas licensure can expect the process to take approximately 2 months to complete once the paperwork is submitted. This 2-month duration does not take into account preparation time for your pharmacist to complete the application and prepare for the testing requirement.

The old adage of Don’t Mess with Texas applies to the pharmacy licensing requirements as well. If the pharmacy is not able to name the replacement within ten 10 days, the pharmacy should cease dispensing into Texas.

Currently, there are approximately 15 states that require the PIC associated with the pharmacy license to hold a license in that state. While the licensing requirements vary from state to state, as illustrated with Tennessee and Texas, generally the time for a pharmacist to become licensed in each of those states exceeds the grace period to register the new PIC to your pharmacy’s license.

As this is a requirement for the pharmacy license to be in good standing, in most cases, the pharmacy must stop dispensing into that state until the replacement is licensed, notice is provided to the pharmacy board, and the pharmacy board notifies the pharmacy the license is in good standing (or active).

In the event your PIC for a particular state with this requirement departs, the pharmacy must either meet the state’s requirement for replacement in the given time allotted by that state or cease dispensing into that state until the requirement is met, and the board of pharmacy for that state updates and clears the pharmacy to resume operations.

Having multiple pharmacists licensed in the states where your pharmacy offers services provides many benefits other than proper succession planning for your pharmacy. The PIC is the compliance officer for that state and is charged with knowing the regulations of that state.

For this reason, having a back-up PIC who is also knowledgeable about the state’s requirements is beneficial in ensuring your pharmacy meets the compliance regulations for that state. While some changes are planned, such as retirement or reduction in force, others, such as death or resignation, typically are not.

A pharmacy dispensing into a state having the aforementioned requirements must pre-plan for the unexpected. A pharmacy may build duplication in their ranks by having a back-up who has already met and cleared the licensing requirements for the states requiring a PIC licensed in that state.

In states such as Tennessee and Texas, where the grace period is just enough time to make the change, having a back-up in place may make the difference in your pharmacy’s ability to continue to serve its patients.

About the Author

Lisa LaVigne is an Attorney and Certified HIPAA Professional who has been practicing law since 2005. Ms. LaVigne focuses her practice in highly regulated industries and is currently consulting with a national healthcare alliance working with the integrated specialty pharmacy division. For more information and to connect, please go to https://www.linkedin.com/in/lisa-lavigne-189a672.