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Frequently Asked Questions for Pharmacists on FDA Approved/Unapproved Use

Q: Pharmacists occasionally get prescriptions that are written for drugs approved by FDA but intended for unapproved use. Is it o.k. to fill these prescriptions?

A: The general guiding principal is that physicians are not limited in prescribing nor pharmacists restrained in dispensing drugs by labeling approved by FDA for that product. FDA jurisdiction is limited to the promotion of the product, not its actual use.

There is nothing necessarily irregular or improper about prescribing and dispensing drugs for unapproved uses. There should be some therapeutic basis for prescribing the drug and it is always a “plus” if such support can be found in the scientific literature. There also can be “common sense” judgments made in some cases. One example is the long established use of Mylicon Drops for flatulence in infants. While the product may not be FDA approved for this purpose it is widely used in pediatrics and is not absorbed systemically so negative effects are generally considered to be absent.

Decisions on this issue should be based primarily on therapeutic effect as well as safety and effectiveness and not just the regulatory activities of FDA. If litigation does occur you would be held to the standard of a reasonably prudent pharmacist under the circumstances.


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