Supplement Maker Warned by FDA for Misbranding and Procedural Violations

Per FDA News, Sanapac, a dietary supplement manufacturer, was notified by the Food and Drug Administration for GMP violations, adulterated products, and misbranding products after an inspection in 2016. After an inspection in November, FDA inspectors returned the following month and found numerous issues in regards to the lack of written Standard Operating Procedures for[…]

US and EU Sign Agreement to Mutually Recognize Drug Manufacturing Inspections

In 1998, the European Union (EU) and the US signed the Mutual Recognition Agreement (MRA) with provisions specifically about current Good Manufacturing Practices (cGMPs) for drugs but were unable to start implementation. Since 2014, both the US and European Medicines Agency (EMA) revived agreement talks concerning the cGMP provisions. Starting in 2012 with the passage[…]

NDI Guidance Would Weaken Supplement Industry According to Jarrow Formulas

The New Dietary Ingredients (NDI) draft guidance will over-regulate and weaken the supplements industry, according to prominent dietary supplements manufacturer, Jarrow Formulas. The Food and Drug Administration (FDA) first issued the NDI guidance in 2011 in an effort to further define the regulations set in the Dietary Supplement Health and Education Act of 1994 (DSHEA)[…]

Louisiana Drug and Supplement Maker Ordered to Stop Production by Courts

Judge Robert G. James of the District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a producer and distributor of several products including drugs and dietary supplements. The owner, Anton S. Botha, was ordered to cease all business operations until he complies with[…]

DEA: Hemp CBD is a Schedule I Drug

Last week, the Drug Enforcement Agency (DEA) ruled that cannabidiol (CBD) falls within the Schedule I drug classification of the Controlled Substances Act (CSA) and has received an official drug code. Companies have 30-days to update their licenses and cease interstate distribution of CBD and other Cannabis-based extracts. States with laws allowing for CBD and[…]

FDA Releases Unique Device Identifier Draft Guidance

Zachary Brennan of the Regulatory Affairs Professional Society (RAPS) outlined the guidance from the Food and Drug Administration (FDA) about the expected content and forms for the Unique Device Identifier (UDI) for medical device manufacturers and distributors that are coming into effect. UDI Background A UDI is composed of: A device identifier One or more[…]

Election 2016: The Future of Pharma Under Clinton

Note: This is not an endorsement of Hillary Clinton. InstantGMP™ will be reporting on various aspects of the Presidential candidates’ platforms and their potential impact. By Kelly L. Waters, Marketing Manager (Ms. Waters does not endorse Clinton, she’s just the author) Last week, we profiled Donald Trump’s proposed plan for pharmaceuticals. Now that the Democratic[…]

Election 2016: The Future of Pharma Under Trump

Note: This is not an endorsement of Donald Trump. InstantGMP™ will be reporting on various aspects of the Presidential candidates’ platforms and their potential impact. By Kelly L. Waters, Marketing Manager (Ms. Waters does not endorse Trump, she’s just the author) Republican Presidential nominee Donald Trump released his proposed health care plan that he would[…]

Turbulence Ahead for Europe’s Pharma Industry Following Brexit

As the votes were being tallied, the entire world had its eye on the UK. The implications of “Brexit” reverberated around the world as it waited with baited breath. In a 52-48 majority, the UK decided to exit the European Union (EU) after close to 50 years. The actual implementation of Brexit will not be[…]

Dr. Rick Soltero Featured in Vape Mentors Masterclass!

Our very own President, Dr. Rick Soltero, had the opportunity to be part of Vape Mentors masterclass talking about the new regulations coming into effect for manufacturers of e-liquids. Be sure to check it out and check out their other online resources! InstantGMP™ Vape and our Standard Operating Procedures for E-Liquids will help your organization[…]