ANCU OTCs Aren’t
Third Class Of Drugs

Any switch-approval rule change from the FDA wouldn’t extend to creating a behind-the-counter category for nonprescription remedies. While NDA sponsors can voluntarily propose making their OTC switches available behind-the-counter, or from pharmacists only, the FDA is authorized to approve drugs either as Rx or nonprescription.

The nonprescription drugs sold required to be sold behind store counters in the US are pseudoephedrine-containing antihistamines, with purchase limits also imposed in a federal law passed in 2006 to prevent use of the products for making methamphetamine.

Levonorgestrel emergency contraceptives, starting with Plan B, initially were voluntarily distributed for behind-the-counter sales in a switch sponsor’s concession to gain FDA approval in 2006. All levonorgestrel products in two 0.75mg doses or one 1.5mg dose in 2013 were ordered to be available OTC by a federal judge, however, surveys show most retailers offering the products kept them in locked display cases.

Additionally, some states require behind the counter sales and restrict purchases to consumers 18 and up for dextromethorphan OTC cough/cold drugs due to the risk of abuse for intoxicating effect.

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