To amend the rule to include information relating to nonacute pain as required by recently enacted legislation.

 

DEPARTMENT OF HEALTH

Division of Medical Quality Assurance

RULE NO.:RULE TITLE:

64B-3.005Counterfeit-Proof Prescription Pads and Blanks for Controlled Sustance Prescribing

PURPOSE AND EFFECT: To amend the rule to include information relating to nonacute pain as required by recently enacted legislation.

SUMMARY: This rulemaking adds information relating to nonacute pain to the counterfeit-proof prescription pad requirements.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 893.065, FS.

LAW IMPLEMENTED: 893.065, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Lola Pouncey, Bureau Chief, 4052 Bald Cypress Way, Bin #C-01, Tallahassee, Florida 32399 or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B-3.005 Counterfeit-Proof Prescription Pads or Blanks for Controlled Substance Prescribing.

(1) No change.

(2) Any person or entity desiring to produce counterfeit-proof prescription pads or blanks for use by prescribing practitioners shall apply to the department for approval. The application shall be made on incorporated by reference form DH-MQA 1250 (05/18 03/12), Application for Counterfeit-Proof Prescription Pad Vendor, which can be obtained at http://www.flrules.org/Gateway/reference.asp?No=Ref-____ 01268, or from the department at Department of Health, 4052 Bald Cypress Way, Bin BCO-01, Tallahassee, Florida 32399-3260, or online at http://www.doh.state.fl.us/mqa/counterfeit-proof.html. To obtain approval, the counterfeit-proof prescription pad or blank must contain the following security features:

(a) through (d) No change.

(3) The counterfeit-proof prescription pad or blank must contain the following information:

(a) through (b) No change.

(c) A place to indicate "NONACUTE PAIN" if the prescription is for the treatment of pain other than acute pain.

(d) A place to indicate "ACUTE PAIN EXCEPTION" if the prescription is for the treatment of acute pain with exceptions as specified in section 456.44, F.S.

(e)(c) No change.

(4) through (5) No change.

Rulemaking Authority 893.065 FS. Law Implemented 893.065 FS. History–New 6-26-08, Amended 6-18-12,_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Lola Pouncey, Chief of General Operations, Bureau of Operations

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 4, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 16, 2018