Lousiana Regulation Revision Committee to Meet April 9, 2013

Tuesday | April 09, 2013 Regulation Revision Committee

Time: 8:00 am - 5:00 pm
Location: Board Office
For more information, contact: Ms. Judy Dinecola, Secretary 

Reminder: Louisiana Board Meeting Tomorrow Feb. 27 to Discuss Patient-Specific or Office Use Prescriptions

2013-E ~ Amends the section of rules that allows pharmacies to prepare practitioner-administered compounds without a patient-specific prescription; specifically authorizes preparation of copies of commercial products when such products are unavailable; limits the amount of products that may be prepared by a pharmacy without a patient-specific prescription to ten percent of total products dispensed and distributed on an annual basis.
               01-23-2013 - Regulation Revision Committee approved Draft #1 (corrected).
               01-29-2013 - Draft #1 amended further.  Board adopted Declaration of Emergency and Emergency Rule with a stipulated effective date of January 31, 2013.
               01-30-2013 - Incorporated as Regulatory Project 2013-1.2.

 

2013-D ~ Repeals the sections of the rules that allow pharmacies to prepare practitioner-administered compounds without a patient-specific prescription.
               12-13-2012 - Board adopted Emergency Rule, with an immediate effective date.
               12-14-2012 - Incorporated as Regulatory Project 2013-1.1.
               01-18-2013 - Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision voided the Emergency Rule effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule reflecting a different balance of risk vs benefit within two weeks.

 

Source found here

Agenda
Louisiana Board of Pharmacy
3388 Brentwood Drive
Baton Rouge, Louisiana 70809-1700
www.pharmacy.la.gov
NOTICE IS HEREBY GIVEN that a Public Hearing has been ordered and called for
9:00 a.m. on Wednesday, February 27, 2013 at the Board office, for the purpose to wit:
A G E N D A
1. Call to Order
2. Appearances
3. Notice of Intent re Regulatory Project 2013-1 ~ Compounding for Prescriber’s Use
4. Notice of Intent re Regulatory Project 2013-2 ~ Satellite Pharmacies
5. Opportunity for Public Comment
6. Adjourn
 

Repost:Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

WEDNESDAY, JANUARY 30, 2013

Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

2013-1 ~ Compounding for Prescriber's Use (aka compounding for office use)               12-13-2012     Board issued Declaration of Emergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing

Reminder of Public Hearing on Issue of Compounding for Prescriber's Use (Office Use) in Louisiana on Feb. 27, 2013

2013-1.1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]
               12-13-2012     Board issued Declaration of Emgergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to all pharmacies, all pharmacists, and List of Interested Parties.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the emergency rule.  The effect of that decision was to void the December 13, 2012 emergency rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.

2013-1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing

Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

2013-1 ~ Compounding for Prescriber's Use (aka compounding for office use)               12-13-2012     Board issued Declaration of Emergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing

source found here

Reminder of Louisiana Board of Pharmacy Meeting 1/29/13 at 8:30

Louisiana Board of Pharmacy
3388 Brentwood Drive
Baton Rouge, Louisiana 70809-1700
www.pharmacy.la.gov
NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and called for 8:30 a.m. on Tuesday, January 29, 2013 at the Board office, for the purpose to wit:
A G E N D A
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 01-16-2013
1. Call to Order
2. Invocation & Pledge of Allegiance
3. Quorum Call
4. Consideration of Replacement Emergency Rule re Compounding for Prescriber’s Use
5. Opportunity for Public Comment
6. Announcements
7. Adjourn

Assessment by Compliance Officers of Compounding Pharmacies of Emegency Rule in Louisiana Begins on January 14, 2013

Board Adopts Emergency Rule re Compounding for Prescriber's Use

Sunday, December 16, 2012

The Board has taken note of the recent tragedies associated with fungal meningitis traced to medications dispensed by a compounding pharmacy in Massachusetts.  That pharmacy was licensed to do business in Louisiana, although none of the cases - to date - have been located within the state.  Further, the Board has learned there are other similar types of pharmacies operating across the country that are also licensed to do business in Louisiana.  Some of these pharmacies specialize in the large-scale preparation of practitioner-administered compounds without a prescription as opposed to compounding medications pursuant to patient-specific prescriptions.  Further, the Board has recently learned that other state boards of pharmacy may have resource limitations that restrict their ability to inspect such facilities on a sufficiently regular basis.

The preparation of compounds in the absence of a patient-specific prescription is construed as manufacturing as opposed to compounding, which is defined in Louisiana pharmacy law as the preparation of medications pursuant to a patient-specific prescription.  Compounding by pharmacies is regulated by the Board of Pharmacy, and manufacturing is regulated by the federal Food & Drug Administration (FDA).  In an abundance of caution for the health, safety and welfare of Louisiana citizens, the Board seeks to repeal the rules which allows pharmacies to compound preparations without the necessity of a patient-specific prescription.  The business entity that wishes to continue the preparation of such products without a prescription may apply to the federal FDA for a manufacturer's registration.

During their December 13, 2012 meeting, the Board adopted this Declaration of Emegency and Emergency Rule.  In recognition of the necessity for practitioners to develop alternative business procedures to acquire needed medications for their patients, the Board has instructed its compliance officers to delay their assessment of compounding pharmacies for compliance with this emergency rule until January 14, 2013.

 

Source located here

 

Louisiana Adopts Emergency Rule Re: Compounding for Prescriber's Use: Patient-Specific Rule

Board Adopts Emergency Rule re Compounding for Prescriber's Use

Sunday, December 16, 2012

The Board has taken note of the recent tragedies associated with fungal meningitis traced to medications dispensed by a compounding pharmacy in Massachusetts. That pharmacy was licensed to do business in Louisiana, although none of the cases - to date - have been located within the state. Further, the Board has learned there are other similar types of pharmacies operating across the country that are also licensed to do business in Louisiana. Some of these pharmacies specialize in the large-scale preparation of practitioner-administered compounds without a prescription as opposed to compounding medications pursuant to patient-specific prescriptions. Further, the Board has recently learned that other state boards of pharmacy may have resource limitations that restrict their ability to inspect such facilities on a sufficiently regular basis.
The preparation of compounds in the absence of a patient-specific prescription is construed as manufacturing as opposed to compounding, which is defined in Louisiana pharmacy law as the preparation of medications pursuant to a patient-specific prescription. Compounding by pharmacies is regulated by the Board of Pharmacy, and manufacturing is regulated by the federal Food & Drug Administration (FDA). In an abundance of caution for the health, safety and welfare of Louisiana citizens, the Board seeks to repeal the rules which allows pharmacies to compound preparations without the necessity of a patient-specific prescription. The business entity that wishes to continue the preparation of such products without a prescription may apply to the federal FDA for a manufacturer's registration.
During their December 13, 2012 meeting, the Board adopted this Declaration of Emegency and Emergency Rule. In recognition of the necessity for practitioners to develop alternative business procedures to acquire needed medications for their patients, the Board has instructed its compliance officers to delay their assessment of compounding pharmacies for compliance with this emergency rule until January 14, 2013.

Louisiana Rules Regarding Advertising: How Many Are Complying With These in The Compounding World?

§1115.  Advertising
A. False, fraudulent, deceptive, or misleading advertising as prohibited by R.S. 37:1241 of the Pharmacy
Practice Act and this section shall include, but is not limited to, any public misrepresentation done or
made with the knowledge, whether actual or constructive, that is untrue or illegal, or is said to be done falsely when the meaning is that the party is in fault for its error.  Actual or constructive knowledge as used in this context shall include intentionally, negligently, mistakenly, or accidentally representing an untrue fact.
B. No person shall carry on, conduct, or transact business under a name which contains a part thereof the words “pharmacist”, “pharmacy”, “apothecary”, “apothecary shop”, “chemist’s shop”, “drug store”, “druggist”, “drugs”, or any word or words of similar or like import, or in any manner by
advertisement, circular, poster, sign, or otherwise describe or refer to a place of business by the terms
of “pharmacy”, “apothecary”, “apothecary shop”, “chemist’s shop”, “drug store”, “drugs”, or any word or words of similar or like import, unless the place of business is a pharmacy validly permitted by the board.
C. Pharmacies and pharmacists are prohibited from advertising professional ability, experience, integrity, or professional qualifications, or soliciting professional practice by means of providing prescribers of prescriptions with prescription forms imprinted with any material referring to a pharmacy or pharmacist.
D. No advertising shall include any reference, direct or indirect, to any controlled dangerous substance as provided for in Schedules II, III, IV, or V of RS. 40:964. The provision of coupons or vouchers for controlled substances through authorized prescribers, which accompany legitimate prescriptions for such controlled substances issued to patients, shall not be prohibited by this section.
AUTHORITY NOTE:  Promulgated in accordance with R.S. 37:1182.
HISTORICAL NOTE:  Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1311
(October 1997), amended LR 29:2089 (October 2003), effective January 1, 2004, amended LR 33:1131 (June 2007).

Rules found here.

General Rules in Lousiana Regarding Compounding Practices

§2535.  General Standards 
A. Compounding Practices.  Compounded medications may be prepared using prescription medications,
over-the-counter medications, chemicals, compounds, or other components.
1. A pharmacy shall have written procedures as necessary for the compounding of drug products
to assure that the finished products have the identity, strength, quality, and purity they are
represented to possess.
2. All compounding shall be accomplished utilizing accepted pharmacy techniques, practices,
and equipment.
3. Products or duplicates of products removed from the market for the purposes of safety shall
not be used to compound prescriptions for human use.
B.   Beyond Use Date.  Compounded medications shall be labeled with a beyond use date of no more than one hundred eighty (180) days, unless documentation on file supports a longer beyond use date.
January 2012 Page 188C. Records and Reports.  Any procedures or other records required to comply with this section shall be maintained for a minimum of two years.
D. Compounding for Prescriber’s Use.  Pharmacists may prepare practitioner administered compounds for a prescriber’s use with the following requirements:
1. an order by the prescriber indicating the formula and quantity ordered to be compounded by
the pharmacist;
2. the product is to be administered by the prescriber and not dispensed to the patient; and
3. the pharmacist shall generate a label and sequential identification number for the compounded
drug.
E. Anticipated Use Products.  The pharmacist shall label any excess compounded product so as to
reference it to the formula used and the assigned lot number and estimated beyond use date based on
the pharmacist’s professional judgment and/or other appropriate testing or published data.
F. 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.

 

There are also additonal rules regarding compounding in Lousiana. Rules are found here.