The Drug Supply Chain Security Act (DSCSA) casts its tentacles widely. There are limits, though, and this post is intended to clarify where those limits are.
Two common and opposing ideas have grown up:
- That physicians are exempt from the Act
- That physicians have to comply with the Act to exactly the same extent as every other entity in the supply chain that stretches from manufacturer to patient.
Neither of these is correct. Only the first, though, will bring the physician grief; the second will merely inflict additional and unnecessary work.
It is not true that every physician practice that inventories drugs must accept and maintain transactional data. Buy-and-bill drugs that are administered by physician practices in the usual course of business are excluded from this requirement. The Drug Quality and Security Act, Title II says that, “notwithstanding any other provision of law, the requirements under paragraphs (1) and (4) shall not apply to licensed healthcare practitioners authorized to prescribe or administer medication under State law or other licensed individuals under the supervision or direction of such practitioners who dispense or administer product in the usual course of professional practice.”
Note that this does not apply to physician practices with in-office dispensing pharmacies; such practices ARE required to comply with transactional data requirements, though the need for compliance is restricted to the pharmacy in the office and does not apply to the practice side of the business.
So what is a dispenser? And, more relevantly, when is a pharmacist a dispenser?
The Act defines a dispenser as “a retail pharmacy, hospital pharmacy, group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.” (Our italics).
This definition, then, includes physicians who dispense and administer prescription drugs, but only if we ignore the exemption quoted above. The requirement for dispensers that relates to product tracing and verification does not apply to physicians and other licensed healthcare practitioners.
That does not mean that DSCSA places no requirement on physicians and other licensed healthcare practitioners. They will be required to use product identifiers when the use of product identifiers for dispensers comes into operation in 2020 and they are required now, and have been since 1st January 2015, to confirm that trading partners are authorized.
It follows that at this time the only requirement the Act lays on physicians who administer prescription drugs in the usual course of their medical practice is to ensure that entities they deal with are authorized trading partners within the terms of the Act; by 2020, they will also have to use product identifiers. Where physician practices have in-office dispensing pharmacies, though, they should also ensure that those dispensing pharmacies comply with all provisions relating to dispensers.
That raises the question: how to ensure that trading partners are authorized? In this connection, verbal confirmation by the trading partner is unlikely to be sufficient and physicians should ensure that the process they go through to confirm a partner’s authorization is documented and can be summoned from whatever archive it is held in when the physician is called on to show what steps they took to confirm authorization. The confirmation can be carried out directly with the trading partner but it must be documented.
Third-party confirmation, though, would be preferable. FDA maintains a database showing all manufacturers and repackagers who are registered. State authorities maintain a register of licensed wholesale distributors, third-party logistics providers and dispensers. There is also an FDA website at www.fda.gov/knowyoursource that lists entities able to confirm that trading partners are properly licensed or registered.
The legislation has teeth. It is a feature of 21st-century life that criminals are continually refining existing methods of deceit and inventing new ones, but FDA cannot be relied on always to assume that the physician who accepts illegal drugs is an innocent party. FDA has in the fairly recent past commenced enforcement actions against physicians and sent letters to physicians identifying those it believes “may have obtained counterfeit or unapproved drugs from a rogue distributor.” No one wants to be the target of one of those enforcement actions or the recipient of one of those letters. However long a physician may have dealt with the trading partner and however illustrious the trading partner’s name, the wise physician (and is there any other kind?) will obtain and document confirmation of registration or licensure.
Free DSCSA Evaluation
Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.