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COPPA at 16
By John R. Fleder – The Children’s Online Privacy Protection Act (“COPPA”) will celebrate its super, sweet 16 next year. The FTC handles most COPPA enforcement and will no doubt…
Update: State Controlled Substance Pharmacy Law Waivers and COVID-19 Response
We previously blogged on a number of pharmacy law waivers issued by state pharmacy regulators in response to COVID-19. Waivers are being updated and added to state pharmacy websites daily…
Main Street Family Pharmacy Compounder Pleads Guilty to Misdemeanor Violations of the FDCA, and Accepts Probation, a $25,000 Fine and a Permanent Injunction
…26 adverse events relating to use of the pharmacy’s MPA. In response to the adverse events, FDA inspected the pharmacy in May and June of 2013, and analyzed samples of…
Pharmacy Compounders Practicing Pursuant to Section 503A Can Get in the Mix: Compounding Shortage Drugs for Hospital Patients, with Some Limitations
…days for products stored refrigerated. (See guidance for PPE and compounding here) If the pharmacy and hospital are not owned/controlled by the same entity, the pharmacy: (1) marks the order…
Identifying and Resolving Red Flags: DEA Continues to “Run it Up the Flagpole”
The Drug Enforcement Administration (“DEA”) recently issued another Final Order revoking a pharmacy registration based on the failure of the pharmacy to meet its corresponding responsibility, more specifically, the failure…
HHS and FDA Finalize Drug Importation Rule and Guidance for New Multi-Market Approved (MMA) Product Category; CMS Provides Guidance for MMA Products under the Medicaid Drug Rebate Program
…(REMS). Drugs that are going to be imported must be approved by the Health Products and Food Branch of Health Canada, and, other than the labeling, meet the conditions in…
FDA’s High Risk Pharmacy Inspections and Enforcement Actions: Coming to a Sterile Compounding Pharmacy Near You?
…the facilities. Of the 29 completed pharmacy inspections, FDA has issued observations (FDA Form 483s) to all but one pharmacy. FDA notes that select Form 483 observations during the inspections…
A Bitter Pill for DEA: GAO Releases its Report on Drug Shortages and DEA’s Management of the Quota System
By Karla L. Palmer – On March 4, 2015, the U.S. General Accountability Office (GAO) released a lengthy and detailed report, titled “Better Management of the Quota Process for Controlled…
A Hard Pill to Swallow? In Transit for a Couple of Years, FDA Finally Coughs Up Draft Guidance on Physical Attributes of Generic Tablets and Capsules
By Kurt R. Karst – Last week, FDA announced the issuance of a long-anticipated draft guidance document, titled “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules,” providing…
New Vermont Law Seeks to Allow Wholesale Importation of Drugs from Canada
On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the…
Vermont Report Finds that the Costs of Prescription Drug Importation May Outweigh Savings
…element of the federal requirements, VAHS set forth to determine whether importing drugs from Canada could result in savings to Vermont consumers. Vermont Medicaid determined that importing drugs from Canada…
Facebook “Pokes” Pharma Companies, Telehealth, and Online Pharmacies
…Canada, and New Zealand, and only to people over the age of 18. So far, so good. This is pretty basic, although other than ensuring that the entities are real…
New Proposed Rule and Draft Guidance Issued to Allow for the Importation of Prescription Drugs
…in July 2019 (see our coverage here). The NPRM describes “Pathway 1” which will allow for the importation of certain prescription drugs from Canada. The Draft Guidance sets forth “Pathway…
DEA Issues Decisions in Pharmacy Cases
…2018, the Acting Administrator revoked the registrations of Trinity Pharmacy I, 83 Fed. Reg. 7220 (Feb. 20, 2018), and Trinity Pharmacy II, 83 Fed. Reg. 7304 (Feb. 20, 2018). Then…
After a Draw in Court, Zogenix and Massachusetts Battle Over ZOHYDRO ER May Have to Proceed to a Penalty Shootout Round
…that “[a] certified pharmacy technician, pharmacy technician, pharmacy technician trainee, or pharmacy intern may not handle [ZOHYDRO ER],” and that before dispensing ZOHYDRO ER a pharmacist must satisfy a bevy…