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FDA: “We are not opposed to patient unit-dose packaging”

March 9, 2010 – 5:20 pm

A while ago we shared a letter from the Healthcare Compliance Packaging Council to FDA regarding an FDA decision out of the Office of Drug Safety “that prohibits generic drug manufacturers from ‘calendarizing’ unit dose blister cards, strips, and other packaging formats.”

We hadn’t heard anything official from FDA, so I asked the agency for an update. Here is the official response, courtesy of two always helpful press contacts, Crystal Rice and Karen Mahoney:

“The Office of Surveillance and Epidemiology evaluates proposed labels and labeling from a medication error perspective.  We are not opposed to patient unit-dose packaging.  However, we want to ensure that the unit-dose pack is designed in a way that is not confusing to the patient or caregiver and makes sense for the dosage and administration of the product.  In certain instances, manufacturers wish to place the days of the week (calendarize) on the unit-dose packaging. However, calendarizing may not be suitable for all medications.  For example, medications that are given on an as-needed basis, or once or twice daily, as opposed to those with fixed doses.  Thus, we evaluate every proposal on a case-by-case basis to determine if the package design and proposal for calendarization makes sense for the dosage and administration of the product and does not contribute to confusion that could lead to dosing errors.”

The good news is that FDA is not opposed to unit-dose packaging, which could put to rest fears that FDA is banning all generic drug manufacturers from using calendarized packaging if the brand drug maker doesn’t.

But could the case-by-case process for reviewing package design and calendarization proposals make some generic drug makers reluctant to introduce something new?

The rush to market can be fierce. I hope that innovation won’t get trampled.

Daphne Allen

  1. 4 Responses to “FDA: “We are not opposed to patient unit-dose packaging””

  2. Interesting thinking about medication packaging. However, I wonder whether there is not another way to look after the compliance issue. Why should each type of medicine be delivered in its specific calendarized packaging? This may be relevant for some chronic disease pathology, but what if patient has to take more than one type of pill? He is supposed to use as much calendarized packagings as needed? I think there is still a real value for pill dispenser solutions.

    By lambert on Mar 10, 2010

  3. The HCPC release in 2009 noted that the decision barring calendarization of unit dose formats was issued by FDA’s Office of Generic Drugs in consultation with the Office of General Counsel. To the best of my knowledge, the Office of Surveillance and Epidemiology was not involved, and may indeed review these matters on a case-by-case basis.

    Nevertheless, FDA’s Office of Generic Drugs is adamant that generic drug manufacturers cannot calendarize a unit-dose blister card unless the manufacturer of the branded version obtained FDA’s consent to do so. Period.

    Unfortunately, this decision by the Office of Generic Drugs could stifle use of calendarized blisters tremendously even when there are no concerns about dosing. It should, however, have no impact whatsoever on greater use of standard unit-dose formats.

    By Peter Mayberry on Mar 15, 2010

  4. Interesting thinking about medication packaging. However, I wonder whether there is not another way to look after the compliance issue. Why should each type of medicine be delivered in its specific calendarized packaging? This may be relevant for some chronic disease pathology, but what if patient has to take more than one type of pill? He is supposed to use as much calendarized packagings as needed? I think there is still a real value for pill dispenser solutions.
    +1

    By Sporter on May 9, 2010

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  2. Mar 22, 2010: Pharmaceutical & Medical Packaging News Insider » More on FDA and Calendarized Unit-Dose Packaging

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