FDA proposing six new rules in the next year

The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of RAPS.org. The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA) of 2013. The following is a brief description of each rule, in order of anticipated or prior proposal release date:

  • Proposal granting FDA authority to destroy low-value drugs that are refused admission into the U.S. (May 6, 2014).
  • Modification of the list of drug products that may not be compounded as a result of the product’s removal from the market, due to safety and efficacy concerns (May 2014).
  • Rules regarding human drug compounding conditions within 503A and 503B facilities (October 2014).
  • Rule outlining the minimum requirements for good manufacturing practices (GMP) at outsourcing facilities (November 2014).
  • Revision of the current requirements regarding annual reports submitted to investigational new drug applications (INDs) to create consistency with the requirements endorsed by the International Conference on Harmonization (ICH). (March 2015).
  • Final rule establishing national standards for licensing prescription drug wholesale distributors and third party logistics providers (November 2015).

To read the full article, click here.

USP and ICH butting heads on elemental impurity standards

Zachary Brennan of in-PharmaTechnologist.com shares that both the U.S. Pharmacopeia (USP) and the ICH are currently updating elemental impurity standards and there are some differences between the two. This could cause costly reformations in the future for companies that must meet these guidelines. Other organizations such as the EU or the Japanese Pharmacopeia declared that they would wait for the ICH to finish before they developed their own standards. David Schoneker, chairman of the Coalition for the Rational Implementation of USP Elemental Impurity Requirements, whom found the situation puzzling, added “There isn’t an imminent safety problem. We want better controls on metals, and we just want better ideas that don’t create waste.” Why do you think the USP went against reasonable time standards to develop impurity standards? Read the full article here.

EMA Attempts To Support Continuous Process Verification With New Guidelines

The European Medicines Agency (EMA) has released draft guidelines regarding continuous process verification (CPV) to bring its policies in line with ICH Q8, Q9, and Q10.  The goal is to gain information a manufacturer can use to make adjustments during production to maintain drug quality, “If appropriate, the product may benefit from a defined period of enhanced sampling and monitoring to help increase process understanding as part of continuous improvement,” the EMA wrote.  While the EMA has acknowledged the benefits CPV can provide, it also says a hybrid approach using traditional process validation is also an option.  To read more, click here.  To view the EMA’s draft guideline, click here.