This final part will cover examples of "labeling" that the FDA will consider along with other issues for a drug product to be moved from prescription to non-prescription status.

• Information leaflets or other documents contained inside the carton or container for the nonprescription drug product
• Text or images on a video display, including interactive displays for consumers to review
• Information displayed on websites
• Statements or questions in a mobile application

Also, applicants may consider proposing one or more additional conditions that consumers must fulfill to ensure that the drug product is safe and effective for nonprescription use, when labeling alone is not sufficient for this purpose.

Examples of additional conditions for safe and effective use that the Agency may consider, particularly with regard to appropriate self-selection and actual use, include, but are not limited to, the following:

• Prior to purchase, the consumer is required to respond to a set of questions on a self- selection test in a mobile application, and the outcome of the self-selection test affirmatively indicates that the consumer is an appropriate candidate to use the nonprescription drug product.
• Prior to purchase, the consumer is required to view and affirm that they viewed text or images in a video that describes how to appropriately use the nonprescription drug product.

As part of the development process for a nonprescription drug product for which an additional condition for nonprescription use will be proposed, applicants should consider how to ensure proper implementation of any additional condition necessary for safe and effective use.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM613666.pdf

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

Pfizer Stops Sales of Injectable Opioids to Veterinarians
Dogs, cats, and other animals are now without Pfizer's injectable opioids. The company has halted sales of the painkillers to veterinarians until sometime next year. It said it won't resume sales for animal use until the shortage at hospitals and surgical facilities has been resolved, which is not expected before the second quarter of 2019.
https://www.fiercepharma.com/pharma/pfizer-halts-injectable-opioid-sales-to-veterinarians-as-shortages-persist

AstraZeneca, Pfizer, Roche, and Johnson & Johnson Being Investigated of Bribing Iraqi Terrorists to Win Contracts
Alleging that certain drug companies paid bribes to terrorists that "openly controlled the Iraqi ministry in charge of importing medical goods," veterans and family member sued the following drug companies last year:

• AstraZeneca,
• Pfizer,
• Roche, and
• Johnson & Johnson.

The plaintiffs contend that the drug companies "obtained lucrative contracts from that ministry by making corrupt payments to the terrorists who ran it."
https://www.fiercepharma.com/pharma/doj-probes-astrazeneca-over-allegations-corruption-iraq

https://www.fiercepharma.com/pharma/roche-johnson-johnson-also-under-justice-department-probe-alleged-terrorist-bribes

BioDiagnostic Int'l Charged by the FDA for Using Filthy Kitchen Utensils to Produce Cervical Biopsy Solution
A California company has been eviscerated in an FDA warning letter after inspectors found it using "kitchen cooking pots and household power tools" to manufacture a drug for vaginal use to stop bleeding after cervical biopsies. The FDA says the drug was produced under filthy conditions by BioDiagnostic Int'l at its plant in Brea, California. BioDiagnostic has recalled all of its products, which are distributed by MedGyn Products, of Addison, Illinois, but the FDA has warned healthcare professionals to avoid them. The agency said there have not been any reports so far of adverse events.
https://www.fiercepharma.com/manufacturing/fda-finds-california-drugmaker-producing-cervical-biopsy-solution-using-kitchen

Did You Know ...

�that Winston Churchill said "A pessimist sees the difficulty in every opportunity; An optimist sees the opportunity in every difficulty."?

Tip of the Week

With all that is going on in pharmaceutical compounding, one might have a tendency to become pessimistic about its future. However, pharmaceutical compounding is critically important and becoming more important over time for a number of reasons. This does not mean we should sit back and watch what happens, but we need to become involved and help shape what happens to ensure patient access to quality compounded preparations.

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Looking Back

In this vale
Of toil and sin,
Your head grows bald,
But not your chin!
     Burma Shave