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FDA Adopts New Rules on Drug Shortages
Practical Law Legal Update 3-617-2545 (Approx. 4 pages)
FDA Adopts New Rules on Drug Shortages
by Practical Law Commercial
| Published on 20 Jul 2015 • USA (National/Federal) |
The Food and Drug Administration (FDA) has recently adopted new rules that require manufacturers of certain pharmaceutical drugs and biological products to notify the FDA when those products are either permanently discontinued or will incur a significant interruption in supply.
On July 8, 2015 the US Food and Drug Administration (FDA) issued final rules amending its regulations that implement provisions of the Food, Drug and Cosmetic Act (FDCA), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), that require manufacturers of certain pharmaceutical drugs and biological products to notify the FDA when those products are either permanently discontinued or will be subject to a significant supply interruption. (80 Fed. Reg. 38915 (July 8, 2015)).
Effective September 8, 2015, manufacturers of certain approved drugs or biological products must notify the FDA electronically of a permanent discontinuance or an interruption in the manufacture of the product that is likely to lead to a meaningful disruption in supply of the product in the US. Manufacturers must notify the FDA at least 6 months prior to the date of the permanent discontinuance or manufacturing interruption or, if a 6 month period is not possible, as soon as practicable, but in no case later than 5 business days after the discontinuance or manufacturing interruption occurs.
These amended rules will only affect prescription products that are:
- Life supporting.
- Life sustaining.
- Intended for use in the prevention or treatment of a debilitating disease or condition.
Products affected by these rule changes include, for example:
- Blood components for transfusions.
- Certain drugs marketed without an approved application.
- Those used during emergency medical care or surgery.
However, radiopharmaceutical products are not covered.
The new rules also:
- Provide that the FDA will issue a noncompliance letter for failures to notify.
- Specify minimum information that manufacturers must include in notifications to the FDA.
- Codify the FDA's current practice of publicly disseminating information on shortages and maintaining public lists of drugs and biological products in shortage.
- Define the terms:
- drug shortage;
- biological product shortage;
- meaningful disruption;
- life supporting or life sustaining; and
- intended for use in the prevention or treatment of a debilitating disease or condition.