One of the most important challenges for wholesale distribution businesses within the pharmaceutical industry is managing Scheduled Drugs, Limits, and Licenses. To control these requirements, many small and start-up pharmaceutical wholesale distributors use manual processes and spreadsheets, but this is often a really time-consuming process and prone to human error, a significant concern for pharma businesses where violations can cause huge fines and therefore the loss of your license to buy and sell the product.
Rather than it’s best to find an ERP software solution that will help to manage Schedules and Limits. Additionally, to all the other regulatory requirements within the pharmaceutical world like Suspicious Order Monitoring, Lot Tracking, and more. Basically, this ERP software will also be able to handle all your operational requirements including purchasing, accounting, financials, and warehouse management.
Overview of Scheduled Drugs
In the US, all drugs, substances, and certain chemicals used to make drugs are classified into 5 distinct categories. These Schedules are supported on the drugs’ acceptable medical use and therefore 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 may cause severe psychological 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 DRUGS:
Some familiar drugs assigned a schedule 1 class include:
- Ecstasy
- Heroin
- LSD
- Marijuana
- Peyote
Schedule II DRUGS:
Some familiar drugs in the schedule 2 class include:
- Cocaine
- Morphine
- Hydrocodone (Vicodin)
- Meperidine (Demerol)
- Methadone
- Methamphetamine
Schedule III DRUGS:
- Ketamine
- Anabolic steroids
- Buprenorphine (Suboxone)
- Codeine and hydrocodone products mixed with aspirin or acetaminophen
Schedule IV DRUGS:
- Ativan
- Ambien
- Clonazepam
- Valium
Schedule V DRUGS:
- Robitussin
- Lyrica
- Lomotil
While the DEA will assign all drugs a Schedule, these Schedules can be changed later and every state can prefer to change the Schedule of a product, as long as it’s never lesser than the Schedule assigned by the DEA. Some produce other specific regulations around drug Schedules. For instance, some states require that any distributor wishing to sell Scheduled drugs in that state must have its “NABP Drug Distributor Accreditation. Having this accreditation is similar to being ISO Certified but in the pharmaceutical industry.
Managing Scheduled Drugs with Pharma ERP
To help simplify drug inventory management, Meta-Pharma (Pharmaceutical ERP) provides many great features in our Pharmaceutical ERP software to maintain accurate information and meet regulations. For pharmaceutical distributors dealing with Scheduled products, Meta-Pharma (Pharmaceutical ERP) ERP allows you to.
- Allot Schedules for both DEA/Federal and States (as applicable) to each product/NDC
- Allot Licenses to each customer ship-to location with expiration dates, track State License information if applicable, and record all associated Schedules the customer can purchase under the specified Licenses
- Inform the software used when a customer’s License is close to its expiration
- If a user changes the ship-to location for an order, Meta-Pharma (Pharmaceutical ERP) 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 Meta-Pharma’s B2B Online Order Portal which gets automatically re-calculated to ensure active Licenses each time.
To further verify license information. Meta-Pharma performs an acceptable License check every time a process is to perform a Sales Order.
As you can see, using Pharmaceutical ERP makes it nearly impossible to violate Schedule and Limit regulations when it comes to selling products to customers. This is just one example of how Meta-Pharma (Pharmaceutical ERP) ERP helps pharmaceutical distributors manage inventory and sell products, without having to manually track and worry about meeting regulations. These pharmaceutical features are just a set of tools available as part of Meta-Pharma (Pharmaceutical ERP)’s full ERP solution.
For more information about the Pharmaceutical ERP solution and a tailored demonstration contact us at Meta-Pharma.