${site.data.firmName}${SEMFirmNameAlt} Rivas Goldstein, LLP Health Care Attorneys
212-541-2451 800-758-3278
A New York Firm Dedicated to Health Care Law

Does your new pharmacy have all of its licenses?

Pharmacies have expanded over the years to become increasingly large and complex. They meet patients’ needs in more ways than ever before.

Of course, this growth has come with government oversight/intervention practices that require pharmacies to have certain licenses, among other things. It is never safe to assume you know what is required. For example, if your retail pharmacy also plans to do wholesale distributing of medications, you likely need a license for wholesale distribution. You also need your traditional retail pharmacy license—and perhaps others.

Federal and state laws

Might your medication supply chain undertakings go across state lines? If so, your pharmacy needs to be compliant with requirements in each state. Federal laws such as the Drug Supply Chain Security Act also require specific licenses for third-party logistics providers and wholesalers. The law comes with reporting and notification requirements as well. This oversight is designed to ensure the nation’s medication supply is as safe as possible (no counterfeit or dangerous drugs, for example).

However, some pharmacies, whether intentionally or not, do run afoul of state and federal laws. Having an attorney can help ensure that your pharmacy meets all regulations.

What happens if you are not compliant?

So what happens if the government unearths evidence that your pharmacy is not compliant with the law in some way? At the very least, you should expect financial penalties. Unfortunately, they could be so severe that they harm your ability to do business in a way that you are able to make a profit. It is also possible that your licenses will be suspended or revoked. Otherwise, you could be put on probation, meaning that even one tiny misstep could lead to a license being yanked.

Of course, you should have the opportunity to fight any accusations of noncompliance. However, prevention goes a long way. Getting everything right up front can save you a lot of trouble down the road. If the temptation to cut a few corners ever rears its head, resist it. Otherwise, the law is likely to catch up to you sooner or later.

No Comments

Leave a comment
Comment Information