One of the biggest challenges for wholesale distribution businesses in the pharmaceutical industry is managing Scheduled Drugs, Limits and Licenses. To help manage these requirements, many small and start-up pharmaceutical wholesale distributors use manual processes and spreadsheets, but this is a very time-consuming process and prone to human error – a serious concern for pharmaceutical businesses where violations can lead to huge fines and the loss of your license to buy and sell product.
Instead, it’s best to find a software solution that can help manage Schedules and Limits in addition to all the other regulatory requirements in the pharmaceutical world such as Suspicious Order Monitoring, Transaction History Management, Lot Tracking and more. Ideally, this piece of software will also be able to handle all your operational requirements including purchasing, accounting, financials, contact management and warehouse management.
A Quick Overview of Schedules
In the United States, all drugs, substances and certain chemicals used to make drugs are classified into 5 distinct categories (known as Schedules). These Schedules are based on the drugs acceptable medical use and the drug’s abuse or dependency (addiction) potential. There are 5 categories (Schedules I through V) starting with Schedule I drugs which have a high potential for abuse and can lead to severe psychological/physical dependence, to Schedule V drugs which have the lowest potential for abuse. Common examples of drugs found under each Schedule are as follows:
Schedule I: Heroin, LSD, Ecstasy
Schedule II: Vicodin, Cocaine, Methadone
Schedule III: Ketamine, Tylenol with less than 90 mg of codeine, Anabolic Steroids
Schedule IV: Ativan, Ambien, Valium
Schedule V: Robitussin, Lyrica, Lomotil
While the DEA will assign all drugs a Schedule, these Schedules can be changed later and each state can choose to change the Schedule of a product, as long as it’s never lower than the Schedule assigned by the DEA. Some states have other specific regulations around drug Schedules. For example, some states require that any distributor wishing to sell Scheduled drugs in that state must have its “NABP Drug Distributor Accreditation” (formerly known as “VAWD” – Verified-Accredited Wholesale Distributors). Having this accreditation is similar to being ISO Certified but in the pharmaceutical industry.
Managing Scheduled Drugs with Bue Link Pharma ERP
To help simplify drug inventory management, Blue Link provides many great features in our Pharmaceutical ERP software to maintain accurate information and meet regulations. For pharmaceutical distributors dealing with Scheduled products, Blue Link ERP allows you to…
Assign Schedules for both DEA/Federal and States (as applicable) to each product/NDC
Assign Licenses to each customer ship-to location with expiration dates, track State License information if applicable, and manage all associated Schedules the customer can purchase under the specified Licenses
State Licenses can only be associated with the specific ship-to State
Notify the software user when a customer’s License is close to its expiration
A color-code system helps users easily identify which customer Licenses are close to expiration or have already expired
Users can also generate reports with information about Licenses that will be expiring soon
Blue Link also has checks in place to prevent product from being added to a Sales Order if there is no active License for the customer’s ship-to location, and when products are entered into a Sales Order, the system automatically checks that there is an acceptable License.
If a user changes the ship-to location for an order, Blue Link performs a re-calculation to determine if the new ship-to has an acceptable License and if not, the system removes the products from the Sales Order.
This includes Sales Orders coming from Blue Link’s B2B Online Order Portal which get automatically re-calculated to ensure active/acceptable Licenses each time.
To further verify license information, Blue Link performs an acceptable License check every time a process is performed on a Sales Order (i.e. printing a pick slip). If there is no acceptable License, the process will not be completed.
As you can see, using Blue Link Pharma ERP makes it nearly impossible to violate Schedule and Limit regulations when it comes to selling product to customers. This is just one example of how Blue Link ERP helps pharmaceutical distributors manage inventory and sell product, without having to manually track and worry about meeting regulations. These pharmaceutical features are just one set of tools available as part of Blue Link’s full ERP solution.