Some pharma manufacturers make special packages of certain drugs that they give away to certain medical practitioners as a way of promoting the product and introducing the practitioner and their patients to it.  The method of distribution is usually through field sales people employed directly by the drug manufacturer, and the drug samples are delivered by them directly to the practitioner.

What could go wrong with that?  Probably diversion of the product contained within the “free sample” packaging back into the supply chain, but without the “free sample” indicator on the package.  Should these special packages be tracked?  Should they be serialized?  You would think the drug manufacturer would have the most to lose if their free samples were diverted, repackaged and resold for a 100% profit.  But what do the regulations say in the growing list of markets around the world that mandate serialization and tracing of drugs?  Let’s have a look.

SOUTH KOREA, BRAZIL (the obsolete RDC-54 anyway), ARGENTINA AND TURKEY

These regulations in all of these markets explicitly require drug samples to be serialized and generally require you to follow the other provisions of the respective regulations for regular drug packages (see each regulation for specifics).

U.S. DSCSA

Surprise!  The U.S. is the only market I could find that explicitly exempts drug samples from the serialization regulations.  The DSCSA serialization and transaction documentation requirements are triggered by any “transaction” in the supply chain.  But the definition of “transaction” specifically eliminates “…the distribution of product samples by a manufacturer or a licensed wholesale distributor…” [see Section 581(24)(B)(v) and “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?”].  I find that a little surprising because the other markets seem to view the distribution of samples as something that could become the target of criminals.  The authors of the DSCSA did not just forget to include samples.  In fact, they went out of their way to say you don’t have to serialize or document their distribution.  They don’t count.

E.U. FMD/EUDR

The E.U. Delegated Regulation is just the opposite.  It not only mentions drug samples, it requires some extra special handling of them.  Article 41 says:

“The marketing authorisation holder intending to supply any of his medicinal products as a free sample […] shall, where that product bears the safety features, indicate it as a free sample in the repositories system and ensure the decommissioning of its unique identifier before providing it to the persons qualified to prescribe it.”

Since there is no exemption of drug samples from bearing the safety features, any drug introduced into the supply chain after February 9, 2019 must bear those safety features, including the unique identifier, which contains the serial number (see “The ‘Unique Identifier’ in the EU Delegated Act”).  When free samples are shipped, the unique identifiers on their packages must be loaded into the E.U. Hub (which will pass the information on to the regional repositories in the region that they will be shipped to).  But that’s not all.  The Marketing Authorization Holder (MAH) must also immediately decommission those same unique identifiers, indicating that they are “free samples”, in the E.U. Hub (see “Decommissioning Under the FMD/EUDR”).  That’s the extra special handling.

The purpose of this extra decommissioning step is that it ensures anyone attempting to authenticate them in the E.U. system of repositories would find that they are already decommissioned because they are free samples.  Article 25, paragraph 1 stipulates that:

“Persons authorised or entitled to supply medicinal products to the public are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products provided to them as free samples…” 

So pharmacies and medical professionals do not need to verify the safety features when they know they are providing drugs to a patient that were provided to them as free samples.  But if someone did not know what they were about to provide to a patient were originally intended by the MAH to be free samples, they would find out when they tried to perform the normal verification in the system of repositories (see “Drug Verification: EU Vs US”).  If that’s a surprise to them, they should report the issue to the proper authorities.

The handling of free samples in markets with a serialization and tracing regulation run the full spectrum, from being exempt, to requiring extra steps.  It will be interesting to see which approach works the best.

Dirk.