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Proposed Pharmacy Rules for Final Rulemaking
– On March 17th, 2008, the proposed language changes to the
following rules was published in the Missouri Register. They are as
follows:
20 CSR 2220-2.010 Pharmacy Standards of
Operations – The Board proposed changes in or new language in
this rule that addressed the following issues:
-
Change in Rule Numbering Nomenclature
contained within the rule regarding the Board transfer from the
Department of Economic Development to the Department of
Insurance, Financial Institutions and Professional Registration.
-
Added language to address that animals of
any type, are not allowed in a pharmacy with the exception of
animals as defined by the American Disabilities Act.
-
Added language requiring temperature must
be maintain “thermostatically” where drugs are stored within the
requirements of USP or the manufacturer.
-
Added language to address the issue of the
storage of pharmacy records at an “off site” location.
-
Added language specifying the time frame to
report technician disciplinary action to the Board and the
required information to be submitted.
-
Added language clarifying records are to be
made available for photocopying by representatives of the board.
20 CSR 2220-2.030 Educational and Licensing
Requirements – The Board proposed changes in or added new
language in this rule that addressed the following issues:
20 CSR 2220-2.036 Temporary License –
The Board proposed changes in or new language in this rule that
addressed the following issues:
-
Change in Rule Numbering Nomenclature
contained within the rule regarding the Board transfer from the
Department of Economic Development to the Department of
Insurance, Financial Institutions and Professional Registration.
-
Added language under Section (11) that a
copy of proof of licensure from the Division of Professional
Registration, Board of Pharmacy website may be used as proof of
licensure by an applicant until delivery of the hard copy of the
license or registration.
-
Language that was contained in Section (11)
was deleted and the same language was placed in a new Section
(12).
20 CSR 2220-2.120 Transfer of Prescription
Information for the Purpose of Refill – The Board proposed
changes in or new language in this rule that addressed the following
issues:
-
Under Section (1), the Board changed
language from the word “may” to “shall”.
-
Under Section (1), a new (E) that speaks to
the requirements in the transfer of a Controlled Substance
prescription between licensed pharmacies.
-
Change in Rule Numbering Nomenclature
contained within the rule regarding the Board transfer from the
Department of Economic Development to the Department of
Insurance, Financial Institutions and Professional Registration.
-
Added language that created a new section
(3), this language addresses the requirement that a pharmacy
must complete the transfer of a prescription within one (1)
business day of receiving the request.
20 CSR 2220-2.220 Sterile Pharmaceuticals
– The Board proposed changes in or new language in this rule that
addressed the following issues:
-
Deleted all sections consisting of Sections
(1 thru 10) of the old Sterile Product rule that was in effect
until June 30th, 2004. These sections were at the very beginning
of the Rule. The amended rule will start with a new numbered
section (1), Definitions.
-
Under old Section (12), New Section (2),
Policies and Procedures have been amended to include “Reference
Materials”. The Board added new language to address the
requirement of reference materials related to sterile
preparations.
-
Under old Section (26), New Section (16),
The Board has added language addressing the use of compounded
sterile preparations from third party contractors under
emergency situations or unanticipated procedures. This language
is critical for health system pharmacies that utilize third
party sterile compounding vendors in the compounding of such
items as cardioplegia solutions.
-
Change in Rule Numbering Nomenclature
contained within the rule regarding the Board transfer from the
Department of Economic Development to the Department of
Insurance, Financial Institutions and Professional Registration.
20 CSR 2220-2.450 Fingerprint Requirements
– The Board proposed changes in or new language in this rule that
addressed the following issues:
-
The Board added language requiring
“Interns” to submit fingerprints in the application process for
Intern licensure.
-
Added language that may require any
applicant for a license, registration or permit to be
fingerprinted again and pay require fingerprinting fees, if the
application process is not completed within six months of
receipt of the application by the Board.
20 CSR 2220-3.040 Return and Reuse of Drugs
and Devices – The Board proposed changes in or new language in
this rule that addressed the following issues:
20 CSR 2220-4.010 General Fees – The
Board proposed changes in or new language in this rule that
addressed the following issues:
-
Due to concerns over the decreasing balance
in the Board of Pharmacy fund due to additional funding mandates
and a lack of a fee increase since the mid-1990’s. The Board is
proposing fee increases in all license, permit and registration
categories.
Notable changes are as follows:
- Original Pharmacy Fee - $300.00
- Pharmacist License Renewal - $225.00
- Pharmacy Renewal Fee - $450.00
- Pharmacy Technician Initial Registration Fee - $35.00
- Pharmacy Technician Renewal Fee - $35.00
-
Additionally, the Board is establishing new
fee’s related to the following:
❍ Score Transfer Fee - $150.00
❍ Pharmacy Classification Change Fee - $50.00
❍ Manager-in Charge Change Fee - $50.00
❍ Pharmacist-in-Charge Change Fee - $50.00
❍ Verification Fee - $25.00
❍ Returned Check Fee - $25.00
❍ Certification of Medication Therapeutic Plan Authority Fee -
$50.00
-
The Delinquent Continuing Education Fee
will now increase to $1000.00
20 CSR 2220-5.030 Definitions and Standards
for Drug Wholesale and Pharmacy Distributors – The Board
proposed changes in or new language in this rule that addressed the
following issues:
-
The Board added language under Section (3)
Minimum standards of practice for drug distributors shall
include the following; in section (B) the Board added the word
“Thermostatically” controlled language regarding the regulation
of temperature in drug storage areas similar to language changes
in Rule 20 CSR 2220-2.010 Pharmacy Standards of Operations.
-
The Board added language under the same
Section (3) in subsection (C), section (10) similar to language
regarding the presence of animals as proposed in Rule 20 CSR
2220-2.010 Pharmacy Standards of Operations.
-
The Board deleted language and added new
language in Section (K) that addresses the availability of
records to representatives of the Board or its agents.
20 CSR 2220-5.070 Standards of Operations
for Medical Gas Distributors - The Board proposed changes in or
new language in this rule that addressed the following issues:
In summary, the Board reviewed and addressed
comments by the public in regards to the proposed changes of the
above rules. The Board moved forward in approval of all of the above
rules for final rulemaking at its April 2008 board meeting. The
final rules are scheduled to be published in the Missouri Register
on July 15th. All proposed changes to the above rules are to go into
effect on August 30th of 2008. Once the final rules are published in
the Missouri Register, MSHP will provide links or copies of the
final rules on www.moshp.org contained in the member section, under
Public Policy Committee.
The Board continued its work on addressing the
outcomes of the 2007 Missouri Legislative session with the
publishing of an emergency rule addressing the administration of
medications by a pharmacist based upon a prescription. The Board
filed the rule on May 1st of 2008 and the rule became effective on
May 11th, 2008. The rule was published in the Missouri Register on
June 2nd of 2008. The rule is titled as follows: 20 CSR
2220-6.040 Administration by Medical Prescription Order. The
rule was published for the required thirty 30 day comment period.
The Board at its July 12th board meeting reviewed all submitted
comments in regards to the emergency rule. The Board received one
comment on the rule. The comment addressed no proposed changes to
the rule, but thanked the Board for the issuance of the rule in a
timely fashion. The Board then approved the rule for final
rulemaking and to be re-published in the Missouri register. Once
again, MSHP will provide links or copies of the emergency rule and
when available the final rule on www.moshp.org contained in the
member section, under Public Policy Committee.
The rule “Administration by Medical
Prescription Order” is very similar in structure and language as the
current rule 20 CSR 2220-6.050 Administration of Influenza per
Protocol.
In summary, the Board reviewed and addressed
comments by the public in regards to the proposed changes of the
above rules. The Board moved forward in approval of all of the above
rules for final rulemaking at its April and July 2008 board
meetings. The final rules approved at the April 2008 meeting are
scheduled to be published in the Missouri Register on July 15th. All
proposed changes to the above rules published in the July 15th
Missouri Register are scheduled to go into effect on August 30th of
2008. The finalize rule on Administration by Medical Prescription
Order approved at the Board meeting on July 12th are to be
published in the Missouri Register at a date to be determined at
this time. However, the rule is in effect at this time under the
emergency rulemaking process. Once the final rules are published in
the Missouri Register, MSHP will provide links or copies of the
final rules on www.moshp.org contained in the member section, under
Public Policy Committee. |
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