Finally! Publication of DSCSA Grandfathering Guidelines
The pharmaceutical industry has reason to celebrate. After a 2-year delay, the U.S. Food and Drug Administration (FDA) has published a grandfathering policy, which specifically
Tag: FDA
November 30, 2017
August 21, 2017
Defining DSCSA Trading Partners
Today FDA issued draft DSCSA compliance guidance on how to identify DSCSA Trading Partners. This draft guidance provides clarity on how to classify trading partner
July 7, 2017
Unmarked Product to Become Risky
One Year Enforcement Delay – Not!? Hidden Timetable in DSCSA Product Identifier Requirements With about 100 working days left until the November 27, 2017 deadline
June 2, 2015
FDA warns Doctors about Risks of Purchasing Unsafe Medications
As of January 1, 2015 the DSCSA mandated that all healthcare practitioners who dispense or administer prescription drugs to patients must purchase their prescription drug
June 2, 2015
Know Your Source
Doctors, nurses, purchasing agents, pharmacists, office managers and other health care professionals are being warned by the FDA to Know Your Source. The FDA is
May 27, 2015
Establishing Supply Network Visibility
Using serialized information to Gain Compliance and Add Business Value All pharmaceutical manufacturers with prescription drugs destined for the United States market must address the
January 6, 2015
FDA Announces DSCSA Enforcement Delay
Trading Partners Get Early New Year’s Gift As a result of industry pressure, the FDA has delayed enforcement of Drug Supply Chain Security Act (DSCSA)
December 2, 2014
HDMA seeks enforcement leniency for DSCSA non-compliance
HDMA urges FDA to Exercise Enforcement Discretion The Healthcare Distribution Management Association (HDMA) recently wrote the FDA and expressed their concern about the pharmaceutical supply
September 24, 2013
UDI Regulation Released for Medical Devices
The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include Unique Device Identifiers, or UDIs, on medical devices. Each
December 17, 2012
FDA Issues Proposed UDI Regulation
July 3, 2012. In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most
