State Pharmacy Boards’ Responses to FDA Form 483 Observations (Resolution 116-1-20)

June 3, 2020

Topics: Resolutions

RESOLUTION NO: 116-1-20
TITLE: State Pharmacy Boards’ Responses to FDA Form 483 Observations
ACTION: PASS

WHEREAS, United States Food and Drug Administration (FDA) frequently conducts inspections of 503A pharmacies and can potentially issue an FDA Form 483, which documents the inspector’s observations and is not a citation or notice of violation of any law or rule; and

WHEREAS, it appears that many FDA Form 483 observations relate to current Good Manufacturing Practice standards, which are applicable to manufacturers and 503B outsourcing facilities but not applicable to pharmacy practice laws, rules, or standards; and

WHEREAS, a pharmacy’s FDA Form 483 may be posted online with or without a response from the pharmacy; and

WHEREAS, some state boards of pharmacy may have taken administrative or disciplinary action against a pharmacy license based solely on a posted FDA Form 483 without firsthand observations made by a state-trained and/or authorized inspector;

THEREFORE BE IT RESOLVED that NABP provide guidance to its member state boards of pharmacy regarding taking disciplinary action against a pharmacy license based solely on observations from an FDA Form 483.

(Resolution passed at the 116th Annual Meeting.)