DSCSA: Who Doesn't Have to Comply?
Not everyone who handles prescription drugs has the same DSCSA duties. Here's who sits outside the main rules, and the mix-ups to avoid.
Chapters
FAQ
Are physicians exempt from DSCSA?
Licensed practitioners who dispense or administer drugs in their practice are exempt from the dispenser tracing and verification requirements in section 582(d).
Which products are excluded from DSCSA?
Among others: blood for transfusion, certain radioactive drugs, imaging drugs, medical gases, certain IV products, some homeopathic drugs, and drugs compounded in compliance with sections 503A or 503B.
Is a drug shortage an emergency under DSCSA?
No. A drug shortage not caused by a public health emergency isn't an emergency medical reason.
Transcript
Not everyone who handles prescription drugs has the same DSCSA duties. Here's who sits outside the main rules, and the mix-ups to avoid. Take a doctor's office that gives drugs to its own patients. Doctors and other licensed prescribers don't follow the pharmacy tracing and checking rules. But other duties, like buying from authorized partners, still apply. Some things aren't DSCSA sales at all. Giving a drug to a patient. A true medical emergency. A small amount for a doctor's office. And selling or merging a pharmacy, when the records go to the new owner. And some products sit outside the law. Think blood for transfusion, certain radioactive drugs, imaging drugs and medical gases. Add certain IV products, some homeopathic drugs, and drugs compounded under the federal rules. Now, two myths. A drug shortage is not an emergency, unless a public health emergency caused it. And you only skip the paperwork with another pharmacy when the sale is for one patient's prescription. Does DSCSA apply to medical devices? Generally no. It covers prescription drugs, although some combination products and kits have their own rules. Your next step: check whether your pharmacy is a dispenser under DSCSA, and whether you're a small dispenser. If you're a pharmacy, our free DSCSA compliance training shows you exactly what applies. Rules can change, so always confirm on FDA.gov.