If you are a pharmacy owner in New York City, you are likely aware of the many regulations and new york state pharmacy laws governing the operation of a pharmacy. While the bulk of these laws and regulations address the safe and legal dispensation of medications, a pharmacy?s business operations are also closely regulated. A NY pharmacists who fails to follow these rules may risk an Office of Professional Conduct (OPD) investigations and other license consequences.
According to the law in New York, pharmacies that are registered with the New York State Board of Pharmacy (Board) are required to report certain changes in their business operations to the Board. These changes are as follows:
1. Renovations
Registered pharmacies that wish to renovate their premises must submit their proposed renovation plans to the Board before they begin to make any changes.
2. Temporary Closings
If a registered pharmacy needs to temporarily close its operations, for whatever reason, the Board must be notified before the scheduled closing takes place, and then again before the scheduled reopening.
3. Natural Disasters
Registered pharmacies that have suffered damage from fire, flood or other disaster are required to contact the Board within 48 hours of the event.
4. Sale of the Business
Since the Board will be issuing a new registration upon the transfer of ownership of a registered pharmacy, the Board recommends that the new owners apply for a new registration approximately six weeks prior to the date of transfer. As with all new registrations, the Board will conduct an inspection before it registers the pharmacy.
5. Change in Corporate Officer/Principal Stockholder
If a registered pharmacy sustains a change in officers or principal stockholders, it must report this event to the Board within 30 days of the change. A principal stockholder is defined by the Board as a holder of 10% or more of the stock of the corporation
6. Supervision Change
Any changes in the supervising staff of a registered pharmacy must be reported to the Board within 7 days of the change.
7. Relocation
If a registered pharmacy wishes to move its location, it must notify the Board at least 30 days prior to the expected date of relocation. An inspection from the Board will likely take place prior to the relocation.
8. Name changes
Any changes to either the corporate name or the assumed name of the pharmacy must be reported to the Board before the pharmacy begins to use the new name.
9. Drug Auctions
The pharmacy must notify the Board at least 7 days before its drugs are sold at an auction. A Board inspector will attend the drug auction.
10. Closing Shop
Before a registered pharmacy discontinues its operation, it must make arrangements for its inventory and records. The Board has established a process for the discontinuance of operation of a registered pharmacy, which must be followed strictly before the pharmacy can close.
If the registered pharmacy is also enrolled with Medicare and/or Medicaid, it is also important to follow each program’s reporting requirements.
Failure to comply with these regulations can result in fines and other penalties, among the gravest of which can be exclusion from Medicare and Medicaid and/or loss of license. The specific penalty will depend heavily on the nature and circumstances of the violation in question.
If you have concerns about your pharmacy’s compliance with the applicable regulations, or you have been contacted by investigators or law enforcement concerning accusations of violations, contact an experienced health care defense attorney at once to protect your rights and your livelihood.
Call our experienced attorneys if your pharmacy license is in jeopardy at (212) 577-6677 to schedule an immediate consultation.