All Permits - Labels and Labeling of Medicinal Drugs

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO.:RULE TITLE:
64B16-28.108All Permits - Labels and Labeling of Medicinal Drugs

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 38, No. 46, October 9, 2012 issue of the Florida Administrative Register.

The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee.  The changes are as follows:

1.  Subsection (2)(h) shall read as follows:

(h) An Expiration Date or a Beyond-Use Date: The expiration date must be the date provided by the manufacturer, repackager, or other distributor. The beyond-use date must not exceed the expiration date and it shall not be a date greater than one year from the date the medicinal drug is filled. The board find that the use of a “discard-after-date” or “do not use after date” to be the equivalent of a beyond-use date.

2.  Subsection (3)(e) shall now read as follows:

(e) Expiration date.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254.