A while back I posted an essay called “Who Is A DSCSA Dispenser?”. I don’t think many actual dispensers read it because about half of the dispensers I run into think the earliest they have to do anything is July of next year. The other half don’t think there is anything in the Drug Supply Chain Security Act (DSCSA) about them at all. Too bad. Both are wrong.
Fortunately I think repackagers know better. At least they should, because the DSCSA contains a lot of specific requirements for them. Repackagers have most of the same requirements that manufacturers do, plus they have many of the wholesale distributor requirements. A double whammy.
Most people in the industry know what a repackager is. Typically they are companies that buy drugs from a manufacturer or a wholesale distributor and then open the packages and put the drug into a new package type. This can include putting the drug into a larger or smaller quantity package, or from bottles into blister cards or even unit dose packs for use in an automated picking machine. It can also include companies who do not buy the drugs but which offer repackaging as a service to the drug owner. It also includes companies that change the label on the manufacturer’s package for whatever reason.
The one thing a repackager should never do is to change the drug itself in anyway. This includes changing the dosage form, diluting, mixing with other solutions or chemicals, etc. Otherwise the company would be considered a manufacturer.
Like manufacturers, repackagers must follow the same current Good Manufacturing Practices (cGMP) to ensure that the product is handled, packaged and labeled properly.
WHO IS A DSCSA REPACKAGER?
The DSCSA defines the term “Repackager” as:
“…a person who owns or operates an establishment that repacks and relabels a product or package for—
(A) further sale; or
(B) distribution without a further transaction.”
To really understand this definition you have to apply the DSCSA definitions of the terms “distribution” and “transaction” as well as those of “product” and “package”. These last two definitions are obvious enough that I won’t show them, but here are the first two:
“The term ‘distribute’ or ‘distribution’ means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with section 503(b)(1) or the dispensing of a product approved under section 512(b).”
“The term ‘transaction’ means the transfer of product between persons in which a change of ownership occurs. …”
I have left out the many exemptions to “transaction” because they are not important to my analysis below. For more about those exemptions, see “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?”.
My interpretation of this set of definitions is that a “DSCSA Repackager” includes any company that does the typical repackaging of drugs that they buy, repackage and then sell. This is clear by clause (A) in the DSCSA definition of “repackager” where it says the repackaged drugs are for “further sale”. But it also appears to include contract repackagers as well as in-house repackaging departments, such as those found in a hospital setting. This comes from the inclusion of companies that repackage drugs for “distribution without a further transaction”.
As you can see, the definition of “distribution” includes receipt, handling, storage and delivery of a product and it does not require a sale, purchase or trade, although those are also part of the definition. Notice the use of the word “or” in that definition. The term “transaction” means a change of ownership. Since a repackager includes companies who repackage drugs that are for distribution without a further change of ownership, that means the term, I believe, includes contract repackaging and in-house repackaging, because ownership, or the lack thereof, does not affect the repackaging operation.
WHAT MUST A REPACKAGER DO TO MEET THE DSCSA?
Section 582 (e) of the DSCSA defines the requirements for repackagers. When accepting ownership of a DSCSA product, a repackager must receive Transaction Information (TI), Transaction History (TH) and a Transaction Statement (TS). Repackagers who do repackaging under contract and do not accept ownership of the product are apparently exempt from this requirement. In-house repackagers operating within a hospital or network under common ownership would apparently not need to receive these documents either, since the larger organization would have already received the product and they are obligated to receive these documents from their supplier (after July 1, 2015 for dispensers).
Of course, any repackager whose output will be subject to additional changes of ownership must provide the next owner with TI, TH and TS.
Contract repackagers may not be exempt from the requirement to serialize the repackaged product by November 27, 2018, but in-house repackagers appear to be. That is, contract repackagers who repackage product that could be reintroduced into the supply chain with a subsequent change of ownership are required to serialize the repackaged drugs by that date. The assumption is that product processed by in-house repackagers will not be sold back into the supply chain.
In-house repackagers are also exempt from having systems in place to enable a repackager to verify suspect product. Repackagers whose output may be subject to further changes of ownership are not exempt and must have those systems by January 1, 2015.
Repackagers of all types must only deal with trading partners who are properly licensed by the end of this year.
There is a lot of diversity in the repackager community but the DSCSA seems to address it fairly well. Do you disagree? Leave a comment below. And if you need help making sense of the regulation, check out “The Drug Supply Chain Security Act Explained”.
Dirk.
