FDA initiates Secure Supply Chain pilot to monitor import Rx safety
ROCKVILLE, Md. The Food and Drug Administration on Wednesday announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States.
“This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “This is one of several agency initiatives to enhance drug product safety.”
“With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate U.S. laws,” added Michael Chappell, acting associate commissioner for Regulatory Affairs at FDA. “Consumers should know that only companies that maintain control over their products will be selected into this pilot program.”
The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program’s criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.
The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot’s criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders.
Each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot’s criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received.
The pilot program is planned to run for a period of two years.
MTI launches Rite Aid Radio
MIAMI BEACH, Fla. Music Technologies International on Tuesday announced that it’s “Rite Aid Radio,” a music and messaging program designed exclusively for Rite Aid, is now available chainwide.
“We relished the opportunity to start from scratch with Rite Aid in creating a music environment that is much more ‘tune’ with their customers,” said Bradley Golden, president of MTI. “We feel that we have helped to create an even more inviting audio ambiance in the stores.”
MTI built the music library song by song to appeal to Rite Aid’s customers, the company stated, and also allows Rite Aid to broadcast messages to speak directly to its customers.
This partnership is actually the resumption of a relationship from the 1990’s when MTI provided a similar program to Rite Aid.
“Our number one priority is keeping our customers happy,” said Jerry Cardinale, Rite Aid senior vice president of indirect procurement. “We feel that MTI’s music and messaging program helps us achieve this goal. MTI shares our philosophy of absolute dedication to customer service.”
Duane Reade announces $3.5 million settlement for Q4 2008
NEW YORK Duane Reade, without admitting liability, has announced a $3.5 million litigation settlement that will result in a $3.5 million one-time, pre-tax charge for the fourth quarter.
The two class action cases concern the retailer’s alleged past payment practices for certain overtime and employee non-exempt classifications.
The settlement is subject to the approval of the U.S. District Court for the Southern District of New York. The company stated that while it believes it can “strongly defend against the matters involved in this litigation” it has decided to settle to avoid additional defense costs and uncertainty surrounding the litigation.
The retailer, which operates 251 stores, is expected to announce its fourth quarter and fiscal year 2008 results in March.