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By Kurt R. Karst – Every few years, interest in the creation of a third category of drug products – something other than prescription or Over-the-Counter (“OTC”) status – is…
…this blog post, 54 companies list OTC hearing aids with FDA under the product code QUF while 18 companies list OTC self-fitting hearing aids under the product code QUH. However,…
…prescription and to those under age 17 with a prescription. Generic equivalents to Plan B are kept behind the pharmacy counter for the prescription product to be lawfully dispensed. What’s…
…on the prescription with all other required elements at the time the practitioner signs the prescription. For an emergency oral prescription, the prescribing practitioner must communicate the information to the…
…an OTC monograph, which basically serves as an instruction manual for making and labeling certain OTC drugs. Relevant to our conversation, OTC monographs establish conditions—such as active ingredients and indications…
…active ingredients that are marketed, albeit at different dosages or indications, both as a prescription and OTC product. For instance, aspirin, while marketed OTC, also has professional labeling for the…
FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a…
…cost of prescription drugs, analysis of manufacturer prices and price increases, the major components of prescription drug pricing along the supply chain, the impacts on insurance premiums and cost sharing,…
…submitted is available OTC or only with a doctor’s prescription, the submission of any Paragraph IV certification entails the very risk that 180-day exclusivity is designed to compensate—namely, that it…
…especially a concern in the context of self-fitting hearing aids. As the Proposed Rule suggested, self-fitting hearing aids are OTC hearing aids, but not all OTC hearing aids are self-fitting….
…ages are common on OTC drug labels. As such, Ms. Sebelius’ claim that cognitive differences between older and younger women requires additional label comprehension studies was found to “reflect[] the…
…of the prescription at the time that it is completed (or, in the case of an emergency oral prescription, directly stating to the pharmacist when such prescription is communicated to…
…to 2009. “Abuse” and “misuse” refer to using a prescription pain reliever to get high, using a prescription pain reliever for pain relief without a prescription or using a prescription…
…FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. All 19 members of the joint Advisory Committee agreed that the benefit-risk profile of Narcan Nasal…
…FDA states is compounding ‘on’ receipt of a valid prescription order consistent with Section 503A(a)(1). Compounding Before Receipt of a Valid Prescription Order A drug may be compounded before…