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USP Joins Alliance for Safe Online Pharmacies

USP announced in a mid-August press release that it had joined the Alliance for Safe Online Pharmacies “to combat the threat posed by the illegal online sale of medicines.” The USP release notes that “nearly 97%” of online pharmacies that do not comply with applicable drug laws and standards.

India to Launch Nationwide Study on Substandard Drugs

The Central Drugs Standard Control Organisation (CDSCO) of India is set to begin a study on what areas of the country have a high concentration of substandard drugs. The study is intended to allow CDSCO to have a more focused investigation of the drug supply chain.

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....

India Offers Bounty for Whistleblowers on Fake Medicines

In a mid-July circular, India’s Central Drugs Standards Control Organisation (CDSCO) announced the offer of rewards for whistleblowers who report on goods that are confirmed as “spurious, adulterated, and/or misbranded.” Rewards have been set at up to 20% of the total value of intercepted shipments of goods. The maximum value of the reward is 2.5m […]

EU Launches Genuine Online Pharmacy Logo Scheme

In late June, EC introduced a logo that will allow patients to identify authorized online pharmacies providing authentic medicines.

FDA and Customs Announce “Trusted Trader Program”

In mid-June, FDA and the US Customs and Border Protection (CBP) announced the launch of a new “Trusted Trader” program meant to expedite the import of products made by companies that are known to meet a quality selection standard. Participants in the program will be given incentives such as exemption from “non-intrusive” inspections. To qualify, participants […]

FDA Issues Draft Guidance on Identifying Suspect Drugs

In early June, FDA announced the release of a draft guidance for industry on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” This is the first guidance issued under Title II of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). It advises drug supply chain stakeholders on how […]

FDA Proposes Reg on Drug Destruction at Border

In early May, FDA proposed a rule spelling out its right to destroy drugs at the border as part of its implementation of section 708 of FDASIA (see IPQ October 24, 2013 and January 23, 2014). In order to better meet the needs of a secure supply chain FDA would now be allowed to destroy […]

HDMA Publishes Guidance on Distributor Compliance with DQSA

In late April, the Healthcare Distribution Management Association (HDMA) published a guidance meant to help distributors comply with the drug supply chain security provisions of DQSA.
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