BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the adoption of New Rule I, the amendment of ARM 37.106.2401, 37.106.2404, 37.106.2405, 37.106.2407, 37.106.2411, 37.106.2412, 37.106.2415, 37.106.2416, 37.106.2420, 37.106.2422, 37.106.2423, 37.106.2430, 37.106.2431, 37.106.2432, and 37.106.2433, and the repeal of ARM 37.106.2406 and 37.106.2426 pertaining to home infusion therapy (HIT)

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NOTICE OF ADOPTION, AMENDMENT, AND REPEAL

 

TO:  All Concerned Persons

 

            1.  On May 28, 2009, the Department of Public Health and Human Services published MAR Notice No. 37-472 pertaining to the public hearing on the proposed adoption, amendment, and repeal of the above-stated rules at page 827 of the 2009 Montana Administrative Register, Issue Number 10.

 

            2.   The department has adopted New Rule I (37.106.2421) as proposed.  The department has amended ARM 37.106.2404, 37.106.2407, 37.106.2411, 37.106.2412, 37.106.2415, 37.106.2416, 37.106.2423, 37.106.2430, 37.106.2431, 37.106.2432, and 37.106.2433, and repealed ARM 37.106.2406 and 37.106.2426 as proposed.

 

            3.  The department has amended the following rules as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:

 

            37.106.2401  HOME INFUSION THERAPY AGENCY:  DEFINITIONS  In addition to the definitions in 50-5-101, MCA, the following definitions apply to this subchapter:

            (1) through (5) remain as proposed.

            (6)  "ISO Class 5" means a classification of air cleanliness as defined in United States Pharmacopoeia (USP) USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations.

            (7) through (13) remain as proposed.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2405  HOME INFUSION THERAPY AGENCY:  ADMINISTRATOR AND PERSONNEL  (1) and (1)(a) remain as proposed.

            (b)  be responsible for ongoing oversight of the home infusion therapy agency's quality assessment system, including the establishment of policies and procedures which address the safe control, accountability, distribution, and administration of infusion products;

            (c) through (7)(d) remain as proposed.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2420  HOME INFUSION THERAPY AGENCY:  POLICY AND PROCEDURE MANUAL  (1)  The home infusion therapy agency shall develop a policy and procedure manual for the organization and operation of the home infusion therapy agency.  A copy of the manual must be kept current at all times, and be readily available at all times, and to all who request it.

            (2) through (3)(x) remain as proposed.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2422  HOME INFUSION THERAPY AGENCY:  PHYSICAL REQUIREMENTS FOR PHARMACIES  (1) remains the same.

            (a)  a separate room with a closed door, isolated from other areas with restricted entry or access, and designed to avoid unnecessary traffic and airflow disturbances from activity as required by United States Pharmacopoeia (USP) USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations;

            (b) through (d) remain as proposed.

            (2)  If a home infusion therapy agency elects to use a Compounding Aseptic Isolator (CAI), the "separate room" requirement of (1)(a) is not required, provided that the home infusion therapy agency maintains documentation of meeting the standards for this exception of CAIs set forth in USP 31 General Chapter 797.

            (2) through (7) remain as proposed but are renumbered (3) through (8).

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            4.  The department has amended ARM 37.106.2401, 37.106.2405, and 37.106.2422 for clarity and consistency.  In ARM 37.106.2401 and 37.106.2422 the acronym USP is not defined, therefore "United States Pharmacopoeia (USP)" is being added to identify the acronym being used as the meaning of this acronym may not be widely recognized.  "Home infusion therapy" is being added in ARM 37.106.2405(1)(b) and 37.106.2420(1) for consistency in identifying home infusion therapy agency references. 

 

            5.  The department has thoroughly considered the comments and testimony received.  A summary of the comments received and the department's responses are as follows:

 

COMMENT #1:  One commentor requested that a Compounding Aseptic Isolator (CAI) be added to ARM 37.106.2422(1)(a) so the description of a pharmacy as a separate room will not be misinterpreted to exclude the use of a CAI that is self-contained and provides the appropriate mixing environment.  The commentor proposed the following language: "Compounding Aseptic Isolators (CAIs) can be placed in a nonsegregated room with conditions that exceed ISO Class 8 particle counts if the manufacturer of the unit can provide documentation that the CAI maintains ISO Class 5 during dynamic operation conditions."

 

RESPONSE #1:  As a CAI is capable of meeting the ISO Class 5 air standards required by United States Pharmacopoeia (USP) 31 General Chapter 797, and the department is proposing incorporation of 797, language allowing the use of CAI is not needed.  However, additional language has been added in response to this comment in relation to a "separate room" or "clean room".  With a vertical or horizontal flow hood, a clean room capable of maintaining an ISO Class 7 environment, as opposed to a Class 8 as proposed by the commentor, is required by 797, but not required if a CAI is used, if rules for exception are met as described in 797.  Therefore, an additional section has been added that clarifies that a "separate room", required in ARM 37.106.2422(1)(a), is not required if a home infusion therapy agency elects to utilize a CAI, but that the agency must maintain documentation of compliance with 797 concerning the exceptions in regards to the CAIs.

 

COMMENT #2:  It was asked how the department will enforce the proposed rules.

 

RESPONSE #2:  The department will enforce the proposed rules in the same manner it enforces current rules, by a process of facility surveys, subsequent generation of statement of deficiencies where noncompliance with those rules are found, and an allowance for the facility to come into compliance.  The proposed rules do not affect the procedure by which the state enforces the home infusion therapy rules.

 

 

 

/s/  Lisa A. Swanson                         /s/  Anna Whiting Sorrell                              

Rule Reviewer                                   Anna Whiting Sorrell, Director

                                                            Public Health and Human Services

           

Certified to the Secretary of State September 14, 2009.