Prescription to OTC Switches A Boon for Pharmacy Front End

Prescription to OTC switches occur when a proven prescription medication gains nonprescription over the counter status.¹ The process is rigorous, requiring manufacturers to submit an efficacy supplement to an already approved New Drug Application. The product must be submitted as-is and in its entirety, “without a change in the previously approved dosage form or route of administration.”² 

Since 1975, at least 106 different ingredients, indications, or dosage strengths have switched from prescription to OTC access; today, there are over 700 medications that once required a prescription available over the counter.³

Staying abreast of the prescriptions that have recently switched, or that may switch in the future, is one way for pharmacy owners to ensure that their store’s front end is stocked with the latest and best OTC products for customers. Read on to learn more about the products that have made the prescription to OTC switch since January 2020.⁴

Olopatadine hydrochloride, 0.2% (Pataday Once Daily Relief)
Approved February 14, 2020
This drug provides temprorary relief of itchy eyes due to pollen, ragweed, grass, animal hair, or dander.

Olopatadine hydrochloride, 0.1% (Pataday Twice Daily Relief)
Approved February 14, 2020
This twice-daily eye drop provides temporary relief for itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander.

Diclofenac sodium (Voltaren Arthritis Pain)
Approved February 14, 2020
Diclofenac sodium provides temporary relief for arthritis pain in various upper (hand, wrist, elbow) and lower (foot, ankle, knee) body locations.

Olopatadine hydrochloride, 0.7% (Pataday Once Daily Relief)
Approved July 13, 2020
Another eyedrop formulation, this strength also provides temporary relief for itchy eyes due to pollen, ragweed, grass, animal hair, or dander.

Ivermectin lotion 0.5% (Sklice)
Approved October 27, 2020
This product is used to treat head lice infestation.

Azelastine hydrochloride nasal spray, 0.15% (Astepro Allergy and Chidlren’s Astepro Allergy)
Approved June 17, 2021
Approved just in time for allergy season, this nasal spray provides temporary relief of nasal congestion, runny or itchy nose, and sneezing due to hay fever or other respiratory allergies.

Alcaftadine ophthalmic solution, 0.25% (Lastacaft)
Approved December 10, 2021
In another win for those living with allergies, this product temporarily relives itchy eyes due to pollen, ragweed, grass, animal hair, and dander.

Mometasone furoate nasal spray, 50 mcg/spray, metered (Nasonex 24HR Allergy)
Approved March 17, 2022
This nasal spray provides temporary relief for nasal congestion, runny or itchy nose, and sneezing resulting from hay fever or other upper respiratory allergies.

Visit the FDA website to view the most up-to-date prescription to OTC switch list.

References

1. Rx-to-OTC switch. Consumer Healthcare Products Association. Accessed July 13, 2022. https://www.chpa.org/our-issues/otc-medicines/rx-otc-switch
2. Small business assistance: Frequently asked questions on the regulatory process of over-the-counter (OTC) drugs. FDA. Reviewed February 24, 2020. Accessed July 13, 2022. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-regulatory-process-over-counter-otc-drugs
3. From prescription pad to store shelf. Why and how some drugs get OK’d for over-the-counter use. Optum. Accessed July 13, 2022. https://www.optum.com/business/health-insights/prescription-vs-otc.html
4. Prescription to over-the-counter (OTC) switch list. FDA. Reviewed March 17, 2022. Accessed July 13, 2022. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/prescription-over-counter-otc-switch-list