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This entry was published on 2019-10-25
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SECTION 6811-C
Patient notification of recalled drugs
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 6811-c. Patient notification of recalled drugs. 1. For purposes of
this section the term "class I recall" shall mean a situation in which
the United States food and drug administration deems there is reasonable
probability that the use of or exposure to a violative product will
cause serious adverse health consequences or death.

2. Where there has been a class I recall of a prescription drug,
pharmacies shall make a reasonable attempt to notify all patients that
have been prescribed and who are currently taking such recalled drug
dispensed from such pharmacy by phone or by mail within three days of
the pharmacy being notified by the United States food and drug
administration, a manufacturer, a wholesaler or by other notice of such
recall.

3. The notification required by this section may be provided by an
individual pharmacy or by a central office in the case of a pharmacy
that is part of a chain.