The Medicare Modernization Act (2003) allows states to enact their own drug importation laws. The Act specifies that such laws would only be valid if the federal government reviewed and approved a state’s proposal to import prescription drugs. Despite the length of time since the passage of the Act, no state has enacted such law
Accepting drugs on false identity – How a wholesaler got into trouble
In 2015, the owner and pharmacist-in-charge of Lane Pharmacy passed away. The Pharmacy, however, carried on as nothing had happened. Allegedly, the Pharmacy continued to operate without a pharmacist. This “unusual” Pharmacy operated until 2017, when the California Board of Pharmacy received a complaint that non-licensed individuals were dispensing medications. The Board investigation revealed that
Are you working with VAWD-accredited wholesalers? How good do you know your wholesaler?
The importance of choosing the right wholesaler cannot be underestimated. With so much emphasis on compliance, a pharmacy cannot succeed if it partners with a wholesaler that does not understand pharmacy business and the requirements placed on pharmacies by PBMs, Boards, and federal agencies. Pharmacy’s profitability largely depends on its wholesalers. Therefore, an effective and
Where do your drugs come from? Criminal cases against healthcare providers purchasing from shady wholesalers.
A physician and his wife were recently sentenced to pay fines of $7,500 and $3,000, respectively, for receiving in interstate commerce and delivering misbranded drugs, a misdemeanor. Read the Department of Justice’s summary of the case here.
The physician specialized in the treatment of cancer patients. His wife was managing the practice and was responsible
Drug Product Identifier rules are delayed.
The FDA has extended the deadline for manufacturers, repackagers, and other distributors to place a drug product identifier at the individual package level for each product introduced into interstate commerce.
Beginning November 27, 2017, manufacturers are required to “affix or imprint a product identifier to each package and homogenous case of product intended to be
Compliance with the Drug Supply Chain Security Act
The Drug Supply Chain Security Act (DSCSA) is also known as Track-and-Trace law. It creates a system to identify and trace certain prescription drugs to improve detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain. The DSCSA has two parts.
Phase I is product tracing. Manufacturers, wholesalers, repackagers, and many
Biosimilars – effect on specialty pharmacy
Biologics are the fastest growing and the most expensive class of drugs on the market. The current cost of biologics is between $50,000 to $250,000 for one year of treatment. FTC Press Release. The numbers are expected to increase even further. Congressional Research.
Biosimilars –on the other hand – are less expensive due