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Proposed OTC Switch Rule Anticipates Digital World

 
• By Malcolm Spicer

FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.

• Source: Shutterstock

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

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More from Rx-to-OTC Switch

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
• By David Ridley

HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

More from Health

Global Alliance Urges UN General Assembly To Put Self-Care At Centre Of NCD Strategy

 
• By David Ridley

Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.

Danes Get OTC Access To ED Treatment

 
• By Tom Gallen

Navamedic has launched Eroxon in Danish pharmacies giving men in the country OTC access to an ED treatment for the first time.

Perrigo Sees Growth Opportunities In Tariff Storm

 
• By Malcolm Spicer

As largest provider of private label/store brand OTCs with “100 plus molecules across 100% price point coverage,” CEO Patrick Lockwood-Taylor says Perrigo’s in position to capitalize as consumers become “more cautious” and look for lower-priced products.