9 Key Capabilities for DEA Controlled Substance Reverse Distribution Partners
All organizations that handle controlled substances, including manufacturers, distributors, pharmacies, and more, will almost certainly need to safely dispose of these materials at some point. Disposal is a risky and complex process—but fortunately, there are partners who can assist and keep drug reverse distribution safe and compliant.
This is part of the normal course of business operations, given drugs expire, are rejected, or go unused. These drugs must be destroyed, or the organization return the creditable material to the manufacturer. These processes must adhere to extremely strict rules from the Drug Enforcement Administration (DEA), to prevent the substances from being lost or stolen. There are also potential state and local regulations.
Errors in the reverse distribution cycle are potentially serious—their consequences can include law violations, as well as:
- Loss of brand image
- Revocation of business license
- Fines/Jail time
- Damage to the community
Controlled Substances Disposal Partnership
When it comes to controlled substance disposal, some organizations don’t want to face the risks of noncompliance and the drain on internal resources in time and administration. They find that the risks and headaches involved in internal management are ample reasons to outsource the disposal program to a third party—one that can deploy specialists to oversee the operation.
However, in making this move, managers must be sure to establish a partnership that minimizes the compliance risk. It’s not worth swapping out the disposal program just to have as much exposure as keeping the program in-house.
Finding a DEA-Approved Partner
To secure the best possible partner, managers must perform due diligence and closely vet the waste disposal or reverse distribution candidate. They can consult the DEA guidelines to confirm the proposed partnership program maintains compliance with federal disposal guidelines. The DEA, however, provides no specific vendor recommendations—so it’s up to the individual ownership or management at a company or facility to select the right partner on its own.
The procurement managers must ensure the partner can support their needs—from formulary and inventory review to documentation and on to waste disposal. During the vetting phase, managers should create a checklist with all the essentials the partner must provide. The most important qualification is that the vendor is currently live with its DEA reverse pharma registration. Lacking this disqualifies a candidate immediately.Ideally, a potential vendor should provide all the components of a reverse distribution program, without any service or support gaps. This will mean it offers a single point of contact, management, and communication. This enables client managers to save time and effort in providing feedback, coordinating processes, and collecting data.
Naturally, as with any waste disposal vendor, it should also offer:
- A list of customer references in the reverse pharma (or a related) industry
- Proven security from the loading dock to the end destination
- Compliance with all relevant state, municipal, and federal laws
- Efficiency to hold costs down
- Accountability throughout the entire process
- An impeccable reputation for honesty
9 Key Capabilities for the Reverse Distribution Market
A partner must offer other capabilities, as well. More specifically, depending on your specific needs, the reverse distribution partner will demonstrate it is:
1. Communications and collaboration-ready: The proven ability to provide a full set of communication processes between your team members and its staff is a top concern. This also involves being able to share key information, such as drug ETA and delivery times. The vendor must also closely interact with your team—not just in communications, but in the overall creation and implementation of shared goals. A partner team fully connected in data and processes can support the successful management and segregation of all the drugs in your facilities.
2. Capable of demonstrating program adaptability: The vendor must implement a program that, while efficient and rigid (as needed), is also adaptable to changing market demands. The vendor must perform formulary review and adapt the protocols to match regulatory changes. The candidate team must also support performance improvement programs: This includes monitoring the performance of current protocols, creating benchmarks, and trying to exceed them.
3. Familiar with official documents: The vendor must be able to manage all paperwork with you easily and prove it can craft a system using form 41/222 documents. The candidate must also be ready to rapidly acquire, format, and send inventory data for your review.
4. Capable of specific consulting/auditing services: As the DEA may launch an audit at any time, the partner must be prepared to constantly review its disposal program. Its team members will check for any changes in regulations, both federal and local, and ensure the program complies with them. The vendor specialists must also be prepared for audits—and coach your team members to be ready for them, as well. Finally, the vendor team must always have the necessary data and forms ready for submission at any and every point.
5. Truck tagging ready: The best vendors seal their trucks when the vehicles are in transit, with unique identification tags. This ensures there is no tampering with the truck’s contents before it arrives at its destination—and this boosts accountability and security.
6. A transportation provider: The partner must maintain its own fleet or have access to a reliable transporter. If it is a third-party logistics provider, it ideally will be a reputable company with reliable and capable drivers.
7. Capable of full disposal: The partner must ensure the drugs are being stored/destroyed at an approved facility. As part of this, extra capabilities should include:
- The ability to provide resources to witness burn (this is crucial)
- The capacity to manage hazardous drugs (when this is needed, it’s crucial)
8. Capable of processing return paperwork: The vendor should be equipped to provide this documentation within 30 days after the transaction. This information also will be stored for DEA audits.
9. Smart technology enabled: The best partners will have cloud-based, secure solutions for tracking processes. These systems can collect data to create documents for formal submission or to power improvement programs.