Proposed Rule Notice
On October 23, 2014, the Montana Board of Pharmacy published a
proposed rule, Montana Administrative Rule Notice No. 24-174-65, to
amend and transfer existing rules related to sterile compounding, interns,
technicians, prescriptions, and the Montana Prescription Drug Registry
(MPDR) program, and to adopt a new rule related to quality assurance.
The notice is available online at www.pharmacy.mt.gov (click on “Regulations,”
then “Rule Notices”).
A public hearing was held on November 13, 2014, and comments were
due November 21, 2014. At the next Board meeting on January 9, 2015,
the Board will discuss the comments received and consider action steps
for final adoption and publication.
General summaries of the proposed rules are listed below.
Proposed Amendments
♦ 24.174.301 Definitions – Updates and adds several new definitions
to accurately reflect current sterile compounding terminology and
standards of practice.
♦ 24.174.411 Pharmacist Meal/Rest Breaks – Clarifies that a pharmacist
may also authorize an intern to remain in the prescription department.
♦ 24.174.602 Internship Requirements – Allows interns additional time
to notify the Board of any address change, similar to the time allotted
to a pharmacist preceptor.
♦ 24.174.701 Registration Requirements – Allows technicians-intraining
additional time to notify the Board of any address change,
similar to the time allotted to a pharmacist preceptor.
♦ 24.174.903 Patient Counseling – Removes the effective date of the
patient counseling area requirements, which became effective in 2003.
♦ 24.174.1101 Personnel – Amends the rule by including additional
requirements when compounding drugs that align with standards
of pharmacy practice, as published by United States Pharmacopeial
Convention (USP).
♦ 24.174.1111 Drug Distribution and Control in an Institutional
Facility – Amends and clarifies the rule regarding requirements for
information that must be obtained and maintained.
♦ 24.174.1115 Use of Contingency Kits in Certain Institutional Facilities
– Clarifies that contingency kit contents and related records must
be made available for Board inspection.
♦ 24.174.1704 Requirements for Submitting Prescription Registry
Information to the Board – Clarifies which pharmacies must report
information to the MPDR and when that information must be reported.
Additionally, the proposed amendment clarifies requirements for
resubmitting corrected data and clarifies the process for submitting
zero reports.
♦ 24.174.2403 Legal Suspension or Revocation – Clarifies that interns
cannot work without supervision.
Proposed Amendments and Transfers
♦ 24.174.510 Prescription Requirements – Defines chart order and
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies.
♦ 24.174.514 Transfer of Prescriptions – Amends the process for
transferring prescriptions, including the involvement of interns in
current pharmacy practice, limiting the transfer of prescriptions for
controlled substances (CS), requiring pharmacies to maintain retrievable
audit trails, and removing the requirement that pharmacists obtain
and maintain forms when patients object to electronic transmission
of their records. Additionally, the proposed rule change transfers the
rule from Subchapter 5 regarding Licensing to Subchapter 8 regarding
Pharmacies.
♦ 24.174.523 Transmission of Prescriptions by Electronic Means –
Strikes the word “only” with regard to when a pharmacist may directly
dispense a Schedule II CS pursuant to a prescription. Additionally,
allows for a prescription by electronic means. The proposed rule also
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies. (Note: The 2015 Montana Legislative Session
will be considering statutory revisions seeking full electronic prescribing
authority for CS in Montana.)
♦ 24.174.1121 Sterile Products – Updates drug compounding
standards to align with standards of pharmacy practice as published
by USP. Additionally, the proposed rule change transfers the rule from
Subchapter 11 regarding Institutional Pharmacies to Subchapter 8
regarding Pharmacies.
Proposed New Rule
♦ New Rule I Quality Assurance Program Requirements – Establishes
a requirement for pharmacies to implement quality assurance programs.
Proposed Transfer of Rules from Subchapter 5 Regarding
Licensing to Subchapter 8 Regarding Pharmacies
♦ 24.174.511 (Labeling for Prescriptions), 512 (Records of Dispensing),
513 (Copy of Prescription), 515 (Emergency Prescription Refills), 520
(Prescription Required for Schedule V), 521 (Returned Prescription),
and 522 (Alternate Delivery of Prescriptions).
2015 Montana Legislative Session
The 64th Session of the Montana Legislature starts in Helena, MT, on
January 5, 2015, and is scheduled to end by April 27, 2015. Information
about legislators, bills, committees, and the Session activities is available
online at http://leg.mt.gov/css/default.asp. As of November 2014, there
have been two bills introduced that would impact the Board:
♦ Senate Bill 7, Revise and extend the prescription drug registry fee; and
♦ Senate Bill 8, Allow electronic prescribing of controlled substances
prescriptions.
In addition, information about the 2013 Senate Joint Resolution 20, an
interim study on prescription drug abuse and prevention in Montana, as well as the work of the Children, Families, Health, & Human Services
Interim Committee 2013-2014 is available online at http://leg.mt.gov/css/
Committees/Interim/2013-2014/Children-Family/default.asp. The Board
provided several presentations and a report about the MPDR program
throughout the 2013-2014 Interim Committee discussions.
quoted from here
On October 23, 2014, the Montana Board of Pharmacy published a
proposed rule, Montana Administrative Rule Notice No. 24-174-65, to
amend and transfer existing rules related to sterile compounding, interns,
technicians, prescriptions, and the Montana Prescription Drug Registry
(MPDR) program, and to adopt a new rule related to quality assurance.
The notice is available online at www.pharmacy.mt.gov (click on “Regulations,”
then “Rule Notices”).
A public hearing was held on November 13, 2014, and comments were
due November 21, 2014. At the next Board meeting on January 9, 2015,
the Board will discuss the comments received and consider action steps
for final adoption and publication.
General summaries of the proposed rules are listed below.
Proposed Amendments
♦ 24.174.301 Definitions – Updates and adds several new definitions
to accurately reflect current sterile compounding terminology and
standards of practice.
♦ 24.174.411 Pharmacist Meal/Rest Breaks – Clarifies that a pharmacist
may also authorize an intern to remain in the prescription department.
♦ 24.174.602 Internship Requirements – Allows interns additional time
to notify the Board of any address change, similar to the time allotted
to a pharmacist preceptor.
♦ 24.174.701 Registration Requirements – Allows technicians-intraining
additional time to notify the Board of any address change,
similar to the time allotted to a pharmacist preceptor.
♦ 24.174.903 Patient Counseling – Removes the effective date of the
patient counseling area requirements, which became effective in 2003.
♦ 24.174.1101 Personnel – Amends the rule by including additional
requirements when compounding drugs that align with standards
of pharmacy practice, as published by United States Pharmacopeial
Convention (USP).
♦ 24.174.1111 Drug Distribution and Control in an Institutional
Facility – Amends and clarifies the rule regarding requirements for
information that must be obtained and maintained.
♦ 24.174.1115 Use of Contingency Kits in Certain Institutional Facilities
– Clarifies that contingency kit contents and related records must
be made available for Board inspection.
♦ 24.174.1704 Requirements for Submitting Prescription Registry
Information to the Board – Clarifies which pharmacies must report
information to the MPDR and when that information must be reported.
Additionally, the proposed amendment clarifies requirements for
resubmitting corrected data and clarifies the process for submitting
zero reports.
♦ 24.174.2403 Legal Suspension or Revocation – Clarifies that interns
cannot work without supervision.
Proposed Amendments and Transfers
♦ 24.174.510 Prescription Requirements – Defines chart order and
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies.
♦ 24.174.514 Transfer of Prescriptions – Amends the process for
transferring prescriptions, including the involvement of interns in
current pharmacy practice, limiting the transfer of prescriptions for
controlled substances (CS), requiring pharmacies to maintain retrievable
audit trails, and removing the requirement that pharmacists obtain
and maintain forms when patients object to electronic transmission
of their records. Additionally, the proposed rule change transfers the
rule from Subchapter 5 regarding Licensing to Subchapter 8 regarding
Pharmacies.
♦ 24.174.523 Transmission of Prescriptions by Electronic Means –
Strikes the word “only” with regard to when a pharmacist may directly
dispense a Schedule II CS pursuant to a prescription. Additionally,
allows for a prescription by electronic means. The proposed rule also
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies. (Note: The 2015 Montana Legislative Session
will be considering statutory revisions seeking full electronic prescribing
authority for CS in Montana.)
♦ 24.174.1121 Sterile Products – Updates drug compounding
standards to align with standards of pharmacy practice as published
by USP. Additionally, the proposed rule change transfers the rule from
Subchapter 11 regarding Institutional Pharmacies to Subchapter 8
regarding Pharmacies.
Proposed New Rule
♦ New Rule I Quality Assurance Program Requirements – Establishes
a requirement for pharmacies to implement quality assurance programs.
Proposed Transfer of Rules from Subchapter 5 Regarding
Licensing to Subchapter 8 Regarding Pharmacies
♦ 24.174.511 (Labeling for Prescriptions), 512 (Records of Dispensing),
513 (Copy of Prescription), 515 (Emergency Prescription Refills), 520
(Prescription Required for Schedule V), 521 (Returned Prescription),
and 522 (Alternate Delivery of Prescriptions).
2015 Montana Legislative Session
The 64th Session of the Montana Legislature starts in Helena, MT, on
January 5, 2015, and is scheduled to end by April 27, 2015. Information
about legislators, bills, committees, and the Session activities is available
online at http://leg.mt.gov/css/default.asp. As of November 2014, there
have been two bills introduced that would impact the Board:
♦ Senate Bill 7, Revise and extend the prescription drug registry fee; and
♦ Senate Bill 8, Allow electronic prescribing of controlled substances
prescriptions.
In addition, information about the 2013 Senate Joint Resolution 20, an
interim study on prescription drug abuse and prevention in Montana, as well as the work of the Children, Families, Health, & Human Services
Interim Committee 2013-2014 is available online at http://leg.mt.gov/css/
Committees/Interim/2013-2014/Children-Family/default.asp. The Board
provided several presentations and a report about the MPDR program
throughout the 2013-2014 Interim Committee discussions.
quoted from here
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