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…name and dosage form, date filled, and quantity dispensed. For electronic prescriptions, the quantity dispensed, date dispensed, and the dispenser must be linked to each electronic prescription record. Id. (codified…
…medicine containing pseudoephedrine, which, under the Combat Methamphetamine Epidemic Act of 2005, is limited to Behind-the-Counter (“BTC”) sales. Previous explorations to create a third category of drugs have petered out. …
…prescription drug price data from payors, providers, prescription drug manufacturers, wholesale drug distributors, and pharmacy benefit managers (PBMs). Previously, only payors and providers needed to report clinical, financial, and quality…
…of simultaneous prescription and OTC marketing of the same drug. As we previously discussed, FDA has relied on FDC Act § 503(b), generally, to assert that, absent a “meaningful difference,”…
…drug is compounded in limited quantities consistent with FDA’s guidance on anticipatory compounding, FDA makes clear that the “drug product must be compounded after receipt of a valid prescription, which…
…in the repository. For each OTC monograph title (e.g., nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g., M002) and an Order ID (e.g., OTC000001) and…
…to distribute controlled substances: distributors, manufacturers, importers, pharmacies, hospital/clinics teaching institutions, practitioners, Mid-level Practitioners (MLP), MLP- Ambulance Services, Researchers, Analytical Labs and NTPs,” but not reverse distributors. The Two-Option Framework…
…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…
…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…
…FDA proposed that, to be a valid prescription order for a compounded drug product, the prescription order needed to state clearly that it is for a compounded drug and necessary…
You may be a doctor, dentist, veterinarian, pharmacy, wholesale distributor, or manufacturer, and you just received an Order to Show Cause from the Drug Enforcement Administration (DEA). An Order to…
…calls on the Department of Justice, the Federal Trade Commission, the Agriculture Department, the Treasury Department, the Department of Commerce, the Department of Health and Human Services (DHHS), and other…
…date the order was received The DEA registration number of the registrant reporting the suspicious order The National Drug Code number, unit, dosage strength, and quantity of the controlled substances…
…25, 2016, in a criminal case, United States v. Vascular Solutions, Inc., on which we previously posted here and here, a jury acquitted Vascular Solutions, Inc. (“VSI”) and its CEO,…
…stating that the MMA product conforms to the information described in the approved application regarding the quality of drug substances, drug products, intermediates, raw materials, reagents, components, in-process materials, container…