Status Report on Rulemaking Activities
(15-01-480)
The Board continues to promulgate new rules as well as revisions
to existing rules. For its clients who have provided their
email addresses, the Board sends electronic Notices of Rulemaking
Activity about these issues.
♦ Regulatory Project 2014-3 ~ Pharmacy Records. The Board
published its Notice of Intent to substantially revise its rules
for pharmacy record keeping on March 20, 2014. After two
public hearings and some revisions to the original proposal,
the Board published the final rule in November 2014, with a
delayed effective date of January 1, 2015. The rule substantially
revised and updated Subchapter B – Pharmacy Records of
Chapter 11 – Pharmacies of the Board’s rules. In addition, the
project made related changes to the records section of Chapter
12 – Automated Medication Systems as well as §1509 – Drug
Distribution Control of Chapter 15 – Hospital Pharmacy.
The rule establishes the standard for positive identification (as
opposed to simple identification) to identify an individual who
prescribes, dispenses, or administers a prescription drug. The
rule then outlines the types of records that require positive identification
and those for which simple identification is sufficient.
The rule identifies two general types of pharmacy dispensing
information systems and requires pharmacies to use one or the
other. Regardless of the type used, the rule identifies the data
elements that must be maintained in the pharmacy dispensing
information system. The rule describes the requirement for
backup and support systems, procedures for purging information
systems, and maintaining audit trails, as well as data
retention requirements and timelines for data production when
requested by the Board. The rule also describes requirements
for the filing of prescription forms and certain allowances for
prescriptions received by facsimile, computer facsimile, and
in electronic format.
♦ Regulatory Project 2014-4 ~ Pharmacy Compounding. During
its August 2014 meeting, the Board received a recommendation
from its Regulation Revision Committee taking note of the
recently enacted federal legislation (Drug Quality and Security
Act of 2013) that limits state-licensed pharmacies to compounding
activities in response to patient-specific prescriptions, with
no authority for compounding preparations in response to purchase
orders from practitioners. The Board voted to allow the
previous emergency rule to expire on August 4, and further,
voted to issue a new emergency rule that became effective on
August 8. That emergency rule seeks to harmonize the Board’s
rule with the recently enacted federal legislation. The Board
republished that emergency rule in December 2014, while pursuing
the promulgation of a permanent rule. The Board completed
that process and will publish the final rule on January 20, 2015.
The permanent final rule will become effective that day and the
temporary emergency rule will then expire. The rule revises
and updates Subchapter C – Compounding of Drugs in Chapter
25 – Prescriptions, Drugs, and Devices.
The rule requires pharmacies engaging in compounding
activities of either sterile or nonsterile preparations to do so
only pursuant to patient-specific prescriptions. Further, the
compounding activities must comply with the relevant chapter
of standards in the United States Pharmacopeia: Chapter
<795> for nonsterile preparations and Chapter <797> for sterile
preparations.
♦ Regulatory Project 2014-5 ~ Prescriptions. The Board published
its Notice of Intent to update its requirements for written and
electronic prescriptions in June 2014. Following two public
hearings and revisions to the original proposal, the Board will
publish the final rule on January 20, 2015; the final rule will
become effective that day. The rule revises and updates §2511 –
Prescriptions of Chapter 25 – Prescriptions, Drugs, and Devices
of the Board’s rules.
The rule establishes a minimum set of data required for all
prescriptions regardless of the medium used – oral, written, or
electronic. With respect to the signature on written prescription
forms (including those sent by facsimile), a manual signature is
required. Examples of invalid signatures include rubber stamps,
signatures of anyone other than the prescriber, and computergenerated
signatures.
♦ Regulatory Project 2014-6 ~ Special Event Pharmacy Permit.
The Board published its Notice of Intent on September 20, 2014,
to develop a new classification of pharmacy permit intended for
use by certain organizations, eg, medical missions, for limited
periods of time. Following a public hearing, the Board will
complete the rulemaking process and publish the final rule on
January 20, 2015, and it will become effective that same day.
The rule creates a new Subchapter B – Special Event Pharmacy
Permit within Chapter 24 – Limited Service Providers. The rule
will enable sponsors of certain types of special public healthrelated
events to apply for and receive a pharmacy permit for
the purpose of operating a pharmacy for a limited period of
time during the special event. The rule establishes licensing
procedures as well as standards of practice.
♦ Regulatory Project 2015-1 ~ Dispenser Reporting to Prescription
Monitoring Program. As indicated in the last issue of this
Newsletter (October 2014), the 2014 Louisiana State Legislature
passed Act 472, which amended the Louisiana Prescription
Monitoring Program (PMP) law to revise the deadline by which
pharmacies and other dispensers of prescriptions for controlled
substances (CS) are required to report those prescription transactions
to the PMP database from the previous deadline of seven
days after the date of dispensing to the next business day after the
date of dispensing. That law became effective on August 1, 2014.
The Board published its Notice of Intent to amend §2911 –
Reporting of Prescription Monitoring Information in Chapter
29 – Prescription Monitoring Program of the Board’s rules to
make the same change required by the legislative act. A public
hearing has been scheduled for January 28, 2015, to receive
comments and testimony on the proposed rule.
♦ Regulatory Project 2015-2 ~ Expiration Date of Schedule II
Prescriptions. As indicated in the last issue of this Newsletter
(October 2014), the 2014 Louisiana State Legislature passed Act
865, which amended the Louisiana Uniform Controlled Dangerous
Substances Law to establish a 90-day expiration date for
prescriptions written for any medication listed in Schedule II.
That law became effective on August 1, 2014.
The Board published its Notice of Intent to amend §2745 – Prescriptions
and §2747 – Dispensing Requirements in Chapter
27 – Controlled Dangerous Substances of the Board’s rules to
make the same change required by the legislative act. A public
hearing has been scheduled for January 28, 2015, to receive
comments and testimony on the proposed rule.
quoted from here
(15-01-480)
The Board continues to promulgate new rules as well as revisions
to existing rules. For its clients who have provided their
email addresses, the Board sends electronic Notices of Rulemaking
Activity about these issues.
♦ Regulatory Project 2014-3 ~ Pharmacy Records. The Board
published its Notice of Intent to substantially revise its rules
for pharmacy record keeping on March 20, 2014. After two
public hearings and some revisions to the original proposal,
the Board published the final rule in November 2014, with a
delayed effective date of January 1, 2015. The rule substantially
revised and updated Subchapter B – Pharmacy Records of
Chapter 11 – Pharmacies of the Board’s rules. In addition, the
project made related changes to the records section of Chapter
12 – Automated Medication Systems as well as §1509 – Drug
Distribution Control of Chapter 15 – Hospital Pharmacy.
The rule establishes the standard for positive identification (as
opposed to simple identification) to identify an individual who
prescribes, dispenses, or administers a prescription drug. The
rule then outlines the types of records that require positive identification
and those for which simple identification is sufficient.
The rule identifies two general types of pharmacy dispensing
information systems and requires pharmacies to use one or the
other. Regardless of the type used, the rule identifies the data
elements that must be maintained in the pharmacy dispensing
information system. The rule describes the requirement for
backup and support systems, procedures for purging information
systems, and maintaining audit trails, as well as data
retention requirements and timelines for data production when
requested by the Board. The rule also describes requirements
for the filing of prescription forms and certain allowances for
prescriptions received by facsimile, computer facsimile, and
in electronic format.
♦ Regulatory Project 2014-4 ~ Pharmacy Compounding. During
its August 2014 meeting, the Board received a recommendation
from its Regulation Revision Committee taking note of the
recently enacted federal legislation (Drug Quality and Security
Act of 2013) that limits state-licensed pharmacies to compounding
activities in response to patient-specific prescriptions, with
no authority for compounding preparations in response to purchase
orders from practitioners. The Board voted to allow the
previous emergency rule to expire on August 4, and further,
voted to issue a new emergency rule that became effective on
August 8. That emergency rule seeks to harmonize the Board’s
rule with the recently enacted federal legislation. The Board
republished that emergency rule in December 2014, while pursuing
the promulgation of a permanent rule. The Board completed
that process and will publish the final rule on January 20, 2015.
The permanent final rule will become effective that day and the
temporary emergency rule will then expire. The rule revises
and updates Subchapter C – Compounding of Drugs in Chapter
25 – Prescriptions, Drugs, and Devices.
The rule requires pharmacies engaging in compounding
activities of either sterile or nonsterile preparations to do so
only pursuant to patient-specific prescriptions. Further, the
compounding activities must comply with the relevant chapter
of standards in the United States Pharmacopeia: Chapter
<795> for nonsterile preparations and Chapter <797> for sterile
preparations.
♦ Regulatory Project 2014-5 ~ Prescriptions. The Board published
its Notice of Intent to update its requirements for written and
electronic prescriptions in June 2014. Following two public
hearings and revisions to the original proposal, the Board will
publish the final rule on January 20, 2015; the final rule will
become effective that day. The rule revises and updates §2511 –
Prescriptions of Chapter 25 – Prescriptions, Drugs, and Devices
of the Board’s rules.
The rule establishes a minimum set of data required for all
prescriptions regardless of the medium used – oral, written, or
electronic. With respect to the signature on written prescription
forms (including those sent by facsimile), a manual signature is
required. Examples of invalid signatures include rubber stamps,
signatures of anyone other than the prescriber, and computergenerated
signatures.
♦ Regulatory Project 2014-6 ~ Special Event Pharmacy Permit.
The Board published its Notice of Intent on September 20, 2014,
to develop a new classification of pharmacy permit intended for
use by certain organizations, eg, medical missions, for limited
periods of time. Following a public hearing, the Board will
complete the rulemaking process and publish the final rule on
January 20, 2015, and it will become effective that same day.
The rule creates a new Subchapter B – Special Event Pharmacy
Permit within Chapter 24 – Limited Service Providers. The rule
will enable sponsors of certain types of special public healthrelated
events to apply for and receive a pharmacy permit for
the purpose of operating a pharmacy for a limited period of
time during the special event. The rule establishes licensing
procedures as well as standards of practice.
♦ Regulatory Project 2015-1 ~ Dispenser Reporting to Prescription
Monitoring Program. As indicated in the last issue of this
Newsletter (October 2014), the 2014 Louisiana State Legislature
passed Act 472, which amended the Louisiana Prescription
Monitoring Program (PMP) law to revise the deadline by which
pharmacies and other dispensers of prescriptions for controlled
substances (CS) are required to report those prescription transactions
to the PMP database from the previous deadline of seven
days after the date of dispensing to the next business day after the
date of dispensing. That law became effective on August 1, 2014.
The Board published its Notice of Intent to amend §2911 –
Reporting of Prescription Monitoring Information in Chapter
29 – Prescription Monitoring Program of the Board’s rules to
make the same change required by the legislative act. A public
hearing has been scheduled for January 28, 2015, to receive
comments and testimony on the proposed rule.
♦ Regulatory Project 2015-2 ~ Expiration Date of Schedule II
Prescriptions. As indicated in the last issue of this Newsletter
(October 2014), the 2014 Louisiana State Legislature passed Act
865, which amended the Louisiana Uniform Controlled Dangerous
Substances Law to establish a 90-day expiration date for
prescriptions written for any medication listed in Schedule II.
That law became effective on August 1, 2014.
The Board published its Notice of Intent to amend §2745 – Prescriptions
and §2747 – Dispensing Requirements in Chapter
27 – Controlled Dangerous Substances of the Board’s rules to
make the same change required by the legislative act. A public
hearing has been scheduled for January 28, 2015, to receive
comments and testimony on the proposed rule.
quoted from here
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