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On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…. . . The FDC Act was amended in 1951 by the Durham-Humphrey Amendment, Pub. L. No. 82-215, 65 Stat. 648 (1951), to give FDA the authority to require that…
A Round Up of New State Laws to Control Drug Prices
…more in any 12-month period, or course of treatment if less than 12 months; biosimilar drugs that have a WAC that is not at least 15% lower than the reference…
DEA Proposes Rule to Expand Partial Filling of Schedule II Prescriptions; Will the Benefit be Cost-Effective?
…and Recovery Act of 2016, Pub. L. No. 114-198, 130 Stat. 695 (codified as amended in scattered sections of 42 U.S.C. and 21 U.S.C.). DEA has now proposed a rule…
GAO Recommends Coordination and Assessment of Federal Efforts to Educate About Prescription Pain Reliever Abuse and Misuse
…pain reliever abuse and misuse increased by 133,000 admissions, (131 percent), from 2003 to 2009; and the annual number of deaths from unintentional overdoses of prescription pain relievers increased by…
What the Doctor Ordered? What the Pharmacist Understood? FDA Issues Compounding Draft Guidance Addressing Compounding for Office Use under FDC Act § 503A
…that demonstrate: (1) appropriate anticipatory compounding (including calculations performed to determine limited quantities that may be compounded before receipt of the prescription); (2) prescription orders bearing notations that the compound…
New Proposed Rule and Draft Guidance Issued to Allow for the Importation of Prescription Drugs
…changes for the MMA products. Drugs offered under an ANDA are not eligible for importation under the Draft Guidance. Under FDC Act § 801(d)(1)(B), 21 U.S.C. § 381(d)(1)(B) , a…
Drug Compounding: FDA Issues Final Guidance on Section 503A’s Individually Identified Prescription Requirement – With At Least Three Noteworthy Changes
…quantity it may compound in advance of receiving prescriptions. (Guidance at 9-10, 9 n. 16). 3. Removing Recordkeeping Requirements to Demonstrate Compliance To the (at least temporary) relief of prescribers…
Oregon Jumps on the Drug Pricing Transparency Bandwagon
…the manufacturer to (1) manufacture the prescription drug, (2) market the prescription drug, (3) distribute the prescription drug, and (4) for ongoing safety and effectiveness research associated with the prescription…
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013…
Obama Pledges To Open Borders for Personal Importation of Prescription Drugs
…of drugs manufactured in the United States by individuals or entities other than manufacturers. In the 1990’s, numerous individuals in the United States began importing prescription drugs (meaning finished products,…
Vermont Report Finds that the Costs of Prescription Drug Importation May Outweigh Savings
…would provide savings to commercial health insurance customers. For 17 prescription drugs, VAHS determined that importation from Canada could result in annual savings between $1 and $5 million. However, VAHS…
Oh Canada! Drug Importation Bills Look North to Address Accessibility and Cost
…valid prescription from a health care provider licensed in the U.S. More products are excluded under H.R. 1480 than S. 469, as H.R. 1480 explicitly excludes controlled substances, biologics, infused…
Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation Law
…2. Dispensing or providing prescription drugs. A licensed retail pharmacy described in section 13731, subsection 1, paragraph B or an entity described in section 13731, subsection 1, paragraph C from…
New REMS for Prescription Oral Sodium Phosphate Products Raises Questions on Application of REMS To Active Ingredients Available Both As Prescription and OTC
…11, FDA issued a press release announcing that it was adding a Black Box warning to two prescription OSP products, Visicol and OsmoPrep, to address the kidney injury, acute phosphate…
GAO Report Assesses State Approaches to Control Pseudoephedrine
…implementation of the CMEA and prescription requirements. After adoption of the prescription requirements in Mississippi in 2010, the number of reported meth lab incidents declined by 66 % in 2011. …