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RxTrace: Is your drug exempt from the Federal Drug Supply Chain Security Act?

Understanding your product’s characteristics and reading certain provisions of the Drug Supply Chain Security Act are keys.

Ever since the Drug Quality and Security Act (DQSA) was signed into law last November, more and more people are asking the question, “Does my drug have to follow the DQSA?” Recently I was on a monthly industry call put on by one of the “Big Three” wholesale distributors to discuss the Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA.

I was surprised how many people asked the wholesaler if their specific product was covered or exempt. Of course, asking a wholesale distributor if your own product must follow a particular Federal law is not likely to get a usable response and that was true in this case, but it did not stop the next person from asking the same kind of question.

In fact, no one can answer that question for you, even the FDA. I can’t answer that question for you. Only YOU can answer that question based on your knowledge of your product’s characteristics and a careful reading of certain provisions of the DSCSA. I can help you with that part.

Application of the DSCSA

In general, many of the provisions of the DSCSA that are related to the movement of product in the supply chain apply only to prescription drugs “…in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution.)“  So if the FDA does not consider your drug to be a prescription drug (“Rx Only”), then it does not need to comply with the DSCSA.

Formally, a “prescription drug” is defined by the law as a drug for human use that is subject to the Food, Drug and Cosmetics Act, Section 503(b)(1). This apparently exempts drugs that are strictly for use only in animals.

Further, if your drug must be sold “behind the pharmacy counter” in some states, that does not make it a prescription drug. Those are state laws and the FDA does not pay attention to state laws when regulating drugs nationally. Even if some states require your drug to be dispensed by a pharmacist only to those who have a physician-issued prescription, if the FDA has not classified it as a prescription drug, then you are off the hook when it comes to following the DSCSA. In these cases, the FDA considers your drug to be Over-The-Counter (OTC), and therefore exempt.

If your product is a device—even if the FDA requires your device to be dispensed only with a physician-issued prescription (“Rx Only”)—then it is not a prescription drug and therefore it is not covered by the DSCSA.

But be careful here. Some devices are classified by the FDA as drug-device or biologic-device Combination Products (CPs). In that case, if the FDA has determined that the Primary Mode of Action (PMOA) of your product is as a drug or a biologic, then your CP is not exempt from the DSCSA (unless the FDA has already informed you that your CP must be labeled with a Unique Device Identifier. If your device has a drug or biologic built into it or in combination with it, check with the FDA’s Office of Combination Products to make sure you understand how they would classify it before deciding to ignore the DSCSA.

Other exemptions

The elimination of drugs that are only for use in animals, OTC products, and devices narrows the application of the DSCSA nicely. But we can go further. Here is a list of products that are explicitly exempt from the DSCSA—hat is, they are not considered DSCSA “products” and are therefore not required to follow the DSCSA regulations:

• Blood or blood components intended for transfusion;

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