DECLARATION OF EMERGENCY
Department of Health and Hospitals
Board of Pharmacy
Compounding for Prescriber Use (LAC 46:LIII.2535)
The Louisiana Board of Pharmacy is exercising the
emergency provisions of the Administrative Procedure Act,
specifically at R.S. 49:953.B, to amend certain portions of its
rules permitting pharmacists to compound medications
intended for administration by practitioners without the
necessity of a patient-specific prescription.
The board has taken note of the recent tragedies associated
with fungal meningitis traced to a compounding pharmacy in
Massachusetts. Further, the board has learned there are other
similar types of pharmacies operating across the country that
are licensed to do business in Louisiana. Some of these
pharmacies specialize in the large-scale preparation of drug
products as opposed to compounding medications pursuant
to patient-specific prescriptions.
The preparation of drug products intended for use in the
general population in the United States is governed by
federal laws and rules administered by the federal Food and
Drug Administration (FDA). Drug manufacturers are
credentialed and regulated by that federal agency, and their
manufacturing activities are required to comply with a set of
quality and safety standards generally known as current
Good Manufacturing Practices (cGMP). There are
provisions within the federal laws and rules that permit state
licensed pharmacies to prepare drug products in response to
patient specific prescriptions. Louisiana-licensed pharmacies
engaged in the compounding of drug preparations in
response to such prescriptions are required to comply with
the set of quality and safety standards published in the
United States Pharmacopeia (USP). By comparison, the USP
standards are less stringent than the cGMP standards.
The board’s current rule permitting pharmacies to
compound products for prescriber use without a patientspecific
prescription contain no limits on products prepared
by pharmacies intended for that general use. As evidenced
by the tragedies referenced earlier, there are risks associated
with pharmacies engaged in manufacturing activities while
adhering to compounding standards. In an effort to mitigate
that risk for Louisiana residents, the board proposes to limit
a pharmacy’s product preparation intended for general use
(including prescriber use) to 10 percent of its total
dispensing and distribution activity. With respect to a
pharmacy’s total dispensing and distribution activity for
Louisiana residents, the board proposes a minimum of ninety
percent be accomplished in response to patient-specific
prescriptions and no more than ten percent for prescriber use
in response to purchase orders.
The board has determined this Emergency Rule is
necessary to prevent imminent peril to the public health,
safety, and welfare. The original Declaration of Emergency
was effective January 31, 2013, and is scheduled to expire
May 30, 2013. Although the board has initiated the
promulgation process necessary to finalize the proposed
rule, it is necessary to re-issue the Emergency Rule to
provide the necessary time to complete the promulgation
process. Therefore, the board has re-issued the Declaration
of Emergency, effective May 29, 2013. The Emergency Rule
shall remain in effect for the maximum time period allowed
under the Administrative Procedure Act or until adoption of
the final Rule, whichever shall first occur.
Title 46
PROFESSIONAL AND OCCUPATIONAL
STANDARDS
Part LIII. PharmacistsChapter 25. Prescriptions,
Drugs, and Devices
Subchapter C. Compounding of Drugs
§2535. General Standards
A - C. …
B. Compounding for Prescriber’s Use. Pharmacists may
prepare practitioner administered compounds for a
prescriber’s use with the following requirements:
1 - 3. …
4. a pharmacy may prepare such products not to
exceed ten percent of the total number of drug dosage units
dispensed and distributed by the pharmacy on an annual
basis.
E. …
F. Compounding Commercial Products Not Available. A
pharmacy may prepare a copy of a commercial product
when that product is not available as evidenced by either of
the following.
1. Products appearing on a website maintained by the
federal Food and Drug Administration (FDA) and/or the
American Society of Health-System Pharmacists (ASHP).
2. Products temporarily unavailable from distributors,
as documented by invoice or other communication from the
distributor.
G. Labeling of Compounded Products
1. For patient-specific compounded products, the
labeling requirements of R.S. 37:1225, or its successor, as
well as this Chapter, shall apply.
2. All practitioner administered compounds shall be
packaged in a suitable container with a label containing, at a
minimum, the following information:
a. pharmacy's name, address, and telephone
number;
b. practitioner's name;
c. name of preparation;
d. strength and concentration;
e. lot number;
f. beyond use date;
g. special storage requirements, if applicable;
h. assigned identification number; and
i. pharmacist's name or initials.
AUTHORITY NOTE: Promulgated in accordance with R.S.
37:1182.
HISTORICAL NOTE: Promulgated by the Department of
Health and Hospitals, Board of Pharmacy, LR 14:708 (October
1988), effective January 1, 1989, amended LR 23:1316 (October
1997), amended LR 29:2105 (October 2003), effective January 1,
2004, amended LR 39:
Malcolm J. Broussard
Executive Director
Source
[PDF]
Department of Health and Hospitals
Board of Pharmacy
Compounding for Prescriber Use (LAC 46:LIII.2535)
The Louisiana Board of Pharmacy is exercising the
emergency provisions of the Administrative Procedure Act,
specifically at R.S. 49:953.B, to amend certain portions of its
rules permitting pharmacists to compound medications
intended for administration by practitioners without the
necessity of a patient-specific prescription.
The board has taken note of the recent tragedies associated
with fungal meningitis traced to a compounding pharmacy in
Massachusetts. Further, the board has learned there are other
similar types of pharmacies operating across the country that
are licensed to do business in Louisiana. Some of these
pharmacies specialize in the large-scale preparation of drug
products as opposed to compounding medications pursuant
to patient-specific prescriptions.
The preparation of drug products intended for use in the
general population in the United States is governed by
federal laws and rules administered by the federal Food and
Drug Administration (FDA). Drug manufacturers are
credentialed and regulated by that federal agency, and their
manufacturing activities are required to comply with a set of
quality and safety standards generally known as current
Good Manufacturing Practices (cGMP). There are
provisions within the federal laws and rules that permit state
licensed pharmacies to prepare drug products in response to
patient specific prescriptions. Louisiana-licensed pharmacies
engaged in the compounding of drug preparations in
response to such prescriptions are required to comply with
the set of quality and safety standards published in the
United States Pharmacopeia (USP). By comparison, the USP
standards are less stringent than the cGMP standards.
The board’s current rule permitting pharmacies to
compound products for prescriber use without a patientspecific
prescription contain no limits on products prepared
by pharmacies intended for that general use. As evidenced
by the tragedies referenced earlier, there are risks associated
with pharmacies engaged in manufacturing activities while
adhering to compounding standards. In an effort to mitigate
that risk for Louisiana residents, the board proposes to limit
a pharmacy’s product preparation intended for general use
(including prescriber use) to 10 percent of its total
dispensing and distribution activity. With respect to a
pharmacy’s total dispensing and distribution activity for
Louisiana residents, the board proposes a minimum of ninety
percent be accomplished in response to patient-specific
prescriptions and no more than ten percent for prescriber use
in response to purchase orders.
The board has determined this Emergency Rule is
necessary to prevent imminent peril to the public health,
safety, and welfare. The original Declaration of Emergency
was effective January 31, 2013, and is scheduled to expire
May 30, 2013. Although the board has initiated the
promulgation process necessary to finalize the proposed
rule, it is necessary to re-issue the Emergency Rule to
provide the necessary time to complete the promulgation
process. Therefore, the board has re-issued the Declaration
of Emergency, effective May 29, 2013. The Emergency Rule
shall remain in effect for the maximum time period allowed
under the Administrative Procedure Act or until adoption of
the final Rule, whichever shall first occur.
Title 46
PROFESSIONAL AND OCCUPATIONAL
STANDARDS
Part LIII. PharmacistsChapter 25. Prescriptions,
Drugs, and Devices
Subchapter C. Compounding of Drugs
§2535. General Standards
A - C. …
B. Compounding for Prescriber’s Use. Pharmacists may
prepare practitioner administered compounds for a
prescriber’s use with the following requirements:
1 - 3. …
4. a pharmacy may prepare such products not to
exceed ten percent of the total number of drug dosage units
dispensed and distributed by the pharmacy on an annual
basis.
E. …
F. Compounding Commercial Products Not Available. A
pharmacy may prepare a copy of a commercial product
when that product is not available as evidenced by either of
the following.
1. Products appearing on a website maintained by the
federal Food and Drug Administration (FDA) and/or the
American Society of Health-System Pharmacists (ASHP).
2. Products temporarily unavailable from distributors,
as documented by invoice or other communication from the
distributor.
G. Labeling of Compounded Products
1. For patient-specific compounded products, the
labeling requirements of R.S. 37:1225, or its successor, as
well as this Chapter, shall apply.
2. All practitioner administered compounds shall be
packaged in a suitable container with a label containing, at a
minimum, the following information:
a. pharmacy's name, address, and telephone
number;
b. practitioner's name;
c. name of preparation;
d. strength and concentration;
e. lot number;
f. beyond use date;
g. special storage requirements, if applicable;
h. assigned identification number; and
i. pharmacist's name or initials.
AUTHORITY NOTE: Promulgated in accordance with R.S.
37:1182.
HISTORICAL NOTE: Promulgated by the Department of
Health and Hospitals, Board of Pharmacy, LR 14:708 (October
1988), effective January 1, 1989, amended LR 23:1316 (October
1997), amended LR 29:2105 (October 2003), effective January 1,
2004, amended LR 39:
Malcolm J. Broussard
Executive Director
Source
DECLARATION OF EMERGENCY Department of Health and ...
doa.louisiana.gov/osr/emr/1306EMR005.pdf
May 29, 2013 - patient specific prescriptions. Louisiana-licensed pharmacies engaged in the compounding of drug preparations in response to such ...
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