A proposed US rule linking information not on a Drug Facts label to an OTC switch approval not long ago would’ve had stakeholders thinking of “behind the counter” distribution with pharmacy and other retail staff advising consumers about whether they should use a certain product.
The Food and Drug Administration’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use”
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