Steps to Take
GET FAMILIAR WITH THE LAW
To avoid any surprise questions when the FDA finally arrives on your doorstep, it’s best to get familiar with all facets of the law. Get comfortable with all the various requirements outlined in the law, along with their respective deadlines. Also, the FDA has issued different guidelines for different supply chain members.
Make sure you understand the specific guidelines required of your organization, along with knowing all the other general supply chain guidelines. If possible, you can also conduct a training session for the other employees so no one is caught off-guard during the audit.
Just knowing all the requirements won’t prepare you for the real thing. Conducting mock audits, on the other hand, can help you get used to the feel of the audit. Not only will it help you get accustomed to the pressure, but it will also allow you to identify and rectify any gaps in your track & trace and data-sharing system, and in your documentation.
LEARN HOW TO REPORT ILLEGITIMATE OR SUSPECT PRODUCTS
Since the whole law is about preventing the entry of fake drugs into the pharma supply chain, it’s imperative you know how to handle the situation if you do encounter an illegitimate product. Fortunately, FDA has laid out the reporting guidelines you need to follow.
The requirements specify that companies must:
- Investigate and quarantine any suspect products and determine whether they are illegitimate or not
- If the product is in fact counterfeit, companies must notify the FDA and the immediate trading partners.
This requirement applies to all authorized trading partners – manufacturers, repackagers, dispensers (pharmacies), and wholesale distributors.