What are some of the regulatory, technical, and clinical hurdles that could potentially impact efforts to reformulate an OTC drug in a new topical application? How might such hurdles be avoided or mitigated to achieve efficient consumer testing?

Topical Medication
Regulatory Affairs
Over the Counter (OTC) Drugs
Consumer Testing
Intellectual Property
Rob Walsh
30 months ago

1 answer


At minimum, one needs to demonstrate “bioequivalence” of the new formulation in terms of pharmacokinetics (ADME - administration, distribution, metabolism, elimination), and also its safety.
Further, the new formulation should offer an advantage to patients; why else should a regulatory agency approve a new formulation?

If the formulation is novel, it could be patented; if we talk about a generic drug, its patent would have expired so the drug could be a part of this invention, perhaps.

Karel Petrak
30 months ago
Maybe; usually just an atomic moiety or two is tweaked for a "new" drug - Dr. David E. 19 months ago

Have some input?