Suppose you get a vial packaging wholesale of vials delivered to you. Each vial is not numbered individually, but the 10ml vial packaging is. Can you offer a doctor a single vial without include a serial number? Okay, let’s break this down.
A doctor is considered a dispenser under the DSCSA and is subject to its regulations. They are obligated to adhere to the DSCSA. Beginning in November of 2020, they, like all dispensers, will be forced to only accept items with serial numbers.
Producers and retailers must nonetheless provide them T3s even though they aren’t obligated to have them (physicians can probably ignore it or throw it away even).
In the past, if a customer only needed one vial, wholesalers would open a 10ml vial packaging and sell it to them individually. That was always a sore spot for the industry’s manufacturers.
In light of the DSCSA, however, the wholesale trade has had to abruptly stop doing so, as it is against the law to sell products that have not been serialised by the manufacturer.
It’s a double-edged sword since it allows manufacturers to specify which products can be sold by distributors, but it also allows distributors to make more money. Dispensers who just need one vial are less likely to buy a 10ml vial packaging of 30, which could lead to lower sales.
They will change their procedure so that they are not stuck with 29 unused vials of a particular medication for too long before they can provide it to another patient. Therefore, it is up to the producer to provide smaller amounts with serial numbers, possibly even serialising each individual vial.
There is a set of rules that wholesalers in the drug supply chain must follow in order to meet the requirements of the DSCSA’s next implementation phase. The serial numbers must be verified on sealed homogeneous cases or on saleable units, and you must only deal with pharmaceuticals that have been properly serialised.
Consider these points as wholesalers plan for the coming year and the 2020 DSCSA deadline, and you’ll find the procedure to be less taxing on your business as a whole.
Needs to be Verified
After the month of November 2020, wholesalers must verify all pharmaceutical shipments using serial numbers, barcodes, and any other identifying data provided by the supplier.
Except in cases where an unlabeled product has been grandfathered in, any inconsistency, like an incorrect National Drug Code (NDC) number or quantity, will necessitate a distinct procedure for quarantining the product or shipping it back.
Rather than waiting until the last minute to identify difficulties and support personnel through an inevitable learning curve, wholesalers should start thinking on how they will receive and manage serialised items as soon as possible.
Analyze Potential Investment Returns Through Technology
By the deadline in November 2020, distributors will have to double-check the P.I. on any returned products they plan to resell. When it comes to reselling pharmaceutical products, one of the most important aspects of the 2020 verification and authentication standards is that wholesalers must be able to provide accurate, compliant documentation.
The process will be difficult because records would need to include the manufacturer’s and returnee’s names and addresses. It is important for wholesalers to start looking into technological solutions that will simplify the process of recording all relevant data for returns, so that they can quickly and easily provide any necessary documentation for resale.
All participants in the medication supply chain can communicate with one another using traceability and serialisation data. Your data management skills are crucial if you’re a wholesaler and want to comply with the DSCSA. One of the greatest obstacles you’ll face on the path to compliance is developing a system to manage this information.
There’s no better time than now to investigate your wholesale business’s data management practises. For instance, a centralised data storage system should be put into place.
The NDC or GTIN and the system for confirming it, storing it, and sharing it with other supply chain participants. It is essential to keep adaptability in mind as this system is being built.
Only half of the DSCSA has been implemented so far, therefore there is still plenty of time for changes. And as a wholesaler, you should think about your own future expansion and budget for a data storage solution that will smooth out any bumps in the road.
Try Not to Anticipate Any Leniency
It’s unclear that wholesalers will be given the same flexibility as retailers in November 2020, even though the FDA was willing to award a one-year extension on the enforcement of their 2019 deadline.
Wholesalers must have a fully functional system in place for collecting data and validating the returns process by this date, and they must also be committed to accepting and selling validated products with the proper identifiers. To achieve these targets, forward-thinking wholesalers should have already made significant investments at the start of 2020.