Pharmacies throughout the country are often looking for ways to improve their business operations and reach additional patients. In some instances, this means a pharmacy may decide to relocate —this may be due to cost considerations, better location opportunities, and other factors. What pharmacies may not know is that a change of location comes with numerous legal obligations related to any State Board of Pharmacy where a pharmacy is licensed. Among these obligations are notification requirements as well as the need for inspections. For example, in Illinois, pharmacies are regulated by the Illinois Department of Financial and Professional Regulations, a department which includes the State’s Board of Pharmacy (“Illinois Board”). Like many states, Illinois has nuanced requirements regarding a change of location for a pharmacy. Any pharmacy that is planning on relocating, whether in Illinois or any other State, must be aware of the unique requirements of their State Board of Pharmacy.
What Licensees Should Know About Relocating a Pharmacy
1. The Application Process
One of the first steps in changing a pharmacy’s location is likely to be an application process. A pharmacy that decides to relocate in Illinois must first complete a new application called the Change of Address, which must be filed at least 90 days prior to the change of location. [1] Failure to accurately complete the application can result in delays of the overall process. In addition, like many states, certain fees must be paid. Applicants must read the application carefully to ensure compliance and accuracy with all requirements. For instance, a State Board of Pharmacy may require supplemental documentation with information pertaining to the names, home addresses, and registered pharmacist numbers of all owners, partners, members, officers, directors, or shareholders owning 5% or more of the pharmacy. Depending on a pharmacy’s ownership structure, additional documentation may need to be submitted including, for corporations, the company’s articles of incorporation. Completion of the entire application process and providing all required supporting documentation is essential to ensure a smooth process associated with the change of location.
2. An Inspection Will Likely Be Required
When a pharmacy wants to relocate, the pharmacy should begin preparing early. Further considering Illinois as an example of this process, in Illinois, a pharmacy cannot relocate until the Illinois Board has inspected and approved of the new location. [2] In this scenario, the pharmacy cannot relocate prior to the inspection of the new premises by the State Board of Pharmacy. Often, after the inspection and the new license is issued, the pharmacy’s medication inventory must be transferred to the new location within 24 hours. [3] This can be a very quick turnaround especially if the pharmacy is not aware of the limited time allotted for transferring medication inventory. In addition, a pharmacy usually cannot relocate unless the pharmacy is actively licensed with its State Board of Pharmacy and has confirmed with the corresponding State Board of Pharmacy that the pharmacy is or will be engaged in the practice of pharmacy, has in stock and will maintain sufficient prescription drugs and materials to serve its patients within a relatively short period of time following the relocation/opening, e.g., 30 days thereafter. [4] After the inspection, the pharmacy must be open to the public for pharmaceutical services in a prompt manner, e.g., within 180 days. [5]
3. Preparing for an Inspection
In instances where an inspection is required before a relocation (or shortly thereafter), the State Board usually has the right to inspect the new pharmacy location at any time. This makes it critical to get the new pharmacy location ready for a full inspection and always maintain it in “inspection ready” condition leading up to the inspection. The following is a list of examples of items that are important to remember when preparing for an inspection:
- Whenever the pharmacy is not occupied by a registrant, the pharmacy must be secured and inaccessible to non-licensed persons, for example through walling off, locking doors, or electronic security equipment. [6]
- All dispensing and drug storage areas of the pharmacy must have a connecting door for access between the pharmacy and drug storage area. [7]
- Refrigerators must only be used for prescription drugs. Food and beverages must be placed in an area away from dispensing practices. Refrigeration must be capable of maintaining temperature that is appropriate for the storage of drugs. [8]
- The pharmacy area cannot be used for storage of merchandise. [9]
- Personal items must be placed in an area away from dispensing activities.[10]
The list above is not necessarily exhaustive of the requirements for a State Board of Pharmacy but provides a sample overview of what a pharmacy can inspect leading up to an inspection. A helpful tool to ensure your pharmacy is compliant with all the requirements of an inspection is to check your State Board’s website. Working with competent legal counsel is also recommended.
Frier Levitt’s State Board of Pharmacy Experience and How Frier Levitt Can Help
Frier Levitt has represented numerous licensees across the country in the pharmacy industry, including in the State of Illinois. Frier Levitt has worked with pharmacies on relocations and other matters involving state licensing boards. Frier Levitt has obtained successful results on behalf of pharmacy clients.
If you are a pharmacy looking to change locations in any state, Frier Levitt is prepared to assist you in the application process as well as preparing for an inspection. Our attorneys take a strategic approach to ensure compliance with state licensing boards. Contact us today to speak with a member of our team.
[1] Illinois. Ill. Admin. Code tit. 68, § 1330.780(c)(1).
[2] Ill. Admin. Code tit. 68, § 1330.400(f)
[3] Id.
[4] See, e.g., Ill. Admin. Code tit. 68, § 1330.500(e)
[5] See, e.g., Ill. Admin. Code tit. 68, § 1330.400(c)
[6] Ill. Admin. Code tit. 68, § 1330.600
[7] Ill. Admin. Code tit. 68, § 1330.610
[8] Id.
[9] Id.
[10] Id.
