This week we will continue looking at the current Draft Memorandum of Understanding recently issued by the FDA for public comment; specifically the highlighted portion below.

3. Substance of Agreement
   1. Investigation of Complaints Relating to Compounded Drug Products Distributed Outside the State
   2. Distribution of Inordinate Amounts of Compounded Drug Products Interstate
   3. Submission and Disclosure of Information

b. Distribution of Inordinate Amounts of Compounded Drug Products Interstate

There are five items in this section:

1. A pharmacy or physician has distributed an inordinate amount of compounded drug products interstate if the number of prescription orders for compounded drug products distributed interstate during any calendar month is greater than 50% of the number of prescription orders for compounded drug products distributed or dispensed both intrastate and interstate by such pharmacy or physician during that month.
   
   
2. At least annually, the State will identify, using surveys, reviewing records during inspections, or other mechanisms, compounding pharmacies that distribute inordinate amounts of compounded drug products interstate.
   
   
3. For physicians distributing compounded drug products interstate, the State will coordinate with the appropriate regulator of physician compounding within the State, as in item #2.
   
   
4. For pharmacies or physicians distributing inordinate amounts of compounded drug products interstate, the State will also collect information regarding:
   • the total number of prescription orders for sterile compounded drugs distributed outside the State;
   • the number of states in which they are licensed or the number of States where compounded products are distributed and
   • whether the State inspected for and found during the most recent inspection that the compounding pharmacy or physician distributed compounded drug products without valid prescription orders for individually identified patients.
   
   
5. The State will notify FDA by email within 30 days of identifying a pharmacy or physician within its jurisdiction distributing inordinate amounts of compounded drug products interstate.

Beginning when the State receives notice of the complaint, the records will be maintained for at least 3 years.

Next week, we will look at:

"c. Submission and Disclosure of Information"

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

Did You Know ...

I'd rather argue against a hundred idiots, than have one agree with me! (Winston Churchill)

Tip of the Week

Webster's definitions of "idiot" are interesting: one in a private station, layman, ignorant person; a feeble-minded person having a mental age not exceeding three years and requiring complete custodial care; a silly or foolish person.

The American Heritage Dictionary defines it as: a mentally deficient person, having intelligence in the lowest measurable range, being unable to guard against common dangers and incapable of learning connected speech; a foolish or stupid person; ignorant person; private person, layman.

I guess we can use whichever one fits the situation. It does, however, seem like there is a "dumbing down" trend in our society and reliance on "cell phones", computers, tablets, technology and other sources for routine daily information. A faculty member once asked a student, "Didn't you learn that in school"? The answer was "No, it isn't necessary to memorize stuff anymore since I can look it up on the internet!" There was silence when the faculty member replied "What do you do when you don't have access to your phone, computer or to the internet or during a power outage?"

We need to encourage individuals to "learn" important information, and not just depend upon electronic devices to look it up as occasions arise.

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Looking Back

One shave lasts,
All day through,
Face feels cool,
And smoother too!
     Burma Shave