The FDA has just released a new DRAFT guidance describing two innovative approaches that may be useful in considering safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is insufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting. These include:

• the development of labeling in addition to the DFL, and
• the implementation of additional conditions so that consumers appropriately self-select and use the product.

These innovative approaches may be useful for applicants intending to develop and seek approval of certain nonprescription drug products through the submission of a new drug application (NDA).

More details next week.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

The FDA Looks at Incentives, Manufacturing "Interventions" to Solve Drug Shortages
The FDA is considering creating a list of "essential drugs" and financial incentives to pharmaceutical manufacturers as it continues to work with the drug shortages that plague U.S. hospitals and pharmacies. FDA Commissioner Scott Gottlieb, M.D., is forming a new Drug Shortages Task Force and named Keagan Lenihan, the FDA's associate commissioner for strategic initiatives to lead it.

"I'm charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge," Gottlieb said. "The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages."
https://www.fiercepharma.com/manufacturing/fda-looks-at-incentives-manufacturing-interventions-to-solve-drug-shortages

Pfizer Stops Production at Hospira Injectables Plant in India
Again, Pfizer has suspended production at a problematic sterile injectables plant in India that the FDA has twice before cited for manufacturing and testing issues. The agency recently outlined problems in a 32-page Form 483 following an inspection of the plant in Irungattukottai, India, a facility that was cited with a Form 483 two years ago and with a warning letter in 2013. The Form includes 11 observations that outline problems with testing and consistency and noted that workers "manipulated test sample weights to obtain passing results" for both batches of raw materials and finished product, according to the FDA.
https://www.fiercepharma.com/manufacturing/pfizer-halts-production-at-india-injectables-plant-after-fda-again-finds-issues

Did You Know ...

�that if you find a job you love, you'll never have to work a day in your life?

Tip of the Week

Growing up, we make a lot of important decisions, not the least of which is "What am I going to do to make a living?" Preparation is required for most jobs today and sometimes that does not come easy. Those individuals wanting to be "instantly ready" to enjoy a job of their choosing are disappointed. Many have grown up obtaining things "instantly" and/or without much effort, so to spend a few years in preparation for a worthy occupation or profession is sometimes a roadblock. However, committing to whatever it takes instills a sense of pride and that sense of pride can produce a sense of love for whatever it is one does to make a living. Pharmacy is a profession that takes a lot of hard work in preparation and throughout ones career, but it is a profession one can love!

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Looking Back

Henry the Eighth,
Sure had trouble,
Short term wives,
Long term stubble!
     Burma Shave