Question of the Day June 2, 2013 With So Many States Addressing Office Use or Prescriber's Use Wouldn't It Make More Sense to Have One Standard Rule or Regulation Whether Through the States or the Federal Government Stating the Terms of Office or Prescriber's Use (Which IS ESSENTIAL TO Doctors, Dentists and Veterinarians)

Louisiana Board of Pharmacy Status of Compounding for Prescriber's Use limited to 10 Percent --Notice of Emergency Rule has been Published and Distributed

2013-1.2 ~ Compounding for Prescriber's Use  [Source: Regulatory Proposal 2013-E]
               01-29-2013     Board issued Declaration of Emergency & Emergency Rule, to become effective on 01-31-2013.
               01-30-2013     Distributed required Notice of Emergency to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
               01-30-2013     Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
               05-29-2013     Board re-issued Declaration of Emergency & Emergency Rule, effective immediately.
               05-30-2013     Distributed required Notice of Emergency Rule to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
               06-01-2013     Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.

letter, notice, and proposed rule can be viewed here

Tennessee New Statute Regarding Office Use

Statute Amended Regarding Compounding
As stated in Public Chapter 266, TCA 63-10-204(4), the definition
of “compounding” includes the following new language:
(D) For use in a licensed prescribing practitioner’s office for
administration to the prescribing practitioner’s patient or
patients when the product is not commercially available
upon receipt of an order from the prescriber;
(E) For use in a health care facility for administration to
a patient or patients receiving treatment or services
provided by the facility when the product is not commercially
available upon receipt of an order from an
authorized licensed medical practitioner of the facility;
(F) For use by emergency medical services for administration
to a patient or patients receiving services from them
under authorized medical control when the product is
not commercially available upon receipt of an order
from a licensed prescriber authorized to provide medical
control; or
(G) For use by a licensed veterinarian for administration
to their non-human patient or patients or for dispensing
to non-human patients in the course of the practice
of veterinary medicine upon receipt of an order from
a veterinarian when the product is not commercially
available.
In TCA 63-10-204(12), the definition of “dispense” now reads
as follows:
. . . “Dispense” means preparing, packaging, compounding
or labeling for delivery and actual delivery of a prescription
drug, nonprescription drug or device in the course of
professional practice to a patient or the patient’s agent, to
include a licensed health care practitioner or a health
care facility providing services or treatment to the patient
or patients, by or pursuant to the lawful order of a
prescriber . . .
TCA 63-10-216 adds this section as follows:
(a) Prior to initial licensure in this state as a compounding
pharmacy, a pharmacy located outside of this state

must have an inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located. Out-of-state pharmacy practice
sites must provide a copy of the most recent inspection
by the regulatory or licensing agency of the state in
which the pharmacy practice site is physically located,
which must have been within the previous twelve (12)
months. Prior to renewal of its license in this state, an
out-of-state pharmacy practice site must provide the
most recent inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located or equivalent regulatory entity,
and which must have been within the previous twelve
(12) months. The board of pharmacy shall have the
right to require additional information before issuing or
renewing a pharmacy license to insure compliance with
applicable laws of this state and any rules and policies
of the board.
(b) Any compounding pharmacy having an active Tennessee
license shall notify the board within fourteen (14)
business days of receipt of any order or decision by a
regulatory agency, other than the Tennessee board of
pharmacy, imposing any disciplinary action, including
any warning, on the pharmacy.
(c) Any pharmacies engaged in sterile compounding must
comply with relevant United States Pharmacopeia (USP)
guidelines as adopted by the board by rule or policy.
(d) Any pharmacies engaging in sterile compounding, except
hospital pharmacies compounding for inpatients of
a hospital, shall report on a quarterly basis to the board
the quantity of sterile compounded products dispensed
in a defined time period in accordance with policies
adopted by the board; provided, however, the executive
director of the board may request this information from
a hospital pharmacy for cause and the hospital pharmacy
shall be required to respond in a timely manner as defined
by the executive director of the board.
The Board plans to discuss rules and policies for additional clarification
to the statute in the near future.
In regard to federal compounding regulations, be advised to
continually monitor United States Code 21 353. The current
regulation may be found at the following Web link: www
.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm155666.htm.

Quoted from Tennessee Board of Pharmacy June 2013 Newsletter

West Virginia Board of Pharmacy Discusses Compounding v. Manufacturing --Compounding for Office Use--Limited Office Use is Permitted --Invoice

Compounding Versus Manufacturing:
Compounding for Office Use
Last quarter, the Board discussed compounding pursuant to
a prescriber’s order (prescription) versus manufacturing. That
article concluded, in part, “ . . . unless it is for a research, teaching
or other similar situation which is not for sale or dispensing,
pharmacies may compound only for individual prescriptions,
or in anticipation of their regular and routine prescriptiondispensing
needs.” However, during the legislative session,
representatives of ophthalmologists expressed concern about
being able to get certain eye drops prepared for their office
use with their patients during certain routine procedures. They
indicated that the solutions are not available on the market and
must be compounded, and that the current law would require
them to write or call in prescriptions for the patient to pick up
and bring with them to appointments. They suggested that this
would be inconvenient and unnecessarily costly for the patients,
often requiring patients to make a second visit because the doctor
would not know until during the initial examination that the
drops would be needed, requiring the exam to be postponed
until the drops could be prescribed, prepared, and picked up
by the patient. As a result, the Board discussed at the March
Board meeting whether to permit limited compounding done
“for office use,” or whether a prescription is always required.
After some discussion, the Board determined that it is in
the best interest of the patient to permit limited compounding
for office use in West Virginia. Therefore, the Board decided
that it would exercise discretion in enforcement with regard
to compounding for that purpose. The motion passed by the
Board stated that this would extend only to minimal amounts of
compounding necessary to fill an order placed by a prescriber

for use in his or her office in the immediate future. No bulk
compounding is permitted under this exception. Further, in no
event, whether for compounded drugs supplied for office use
or any other transfer of prescription drug stock for office use,
may this be documented as a prescription order. Because the
transfer of the compounded product would be done for a prescriber
to have in supply for general office use, the transaction
must be properly documented by invoice the same as any other
wholesale transaction. Finally, this very limited exception does
not in any way change the analysis that all other compounding
must be done for a prescription, or for a research, teaching,
or other similar situation that is not for sale or dispensing, as
required by law.

quoted from West Virginia Board of Pharmacy June 2013 Newsletter

Louisiana Board of Pharmacy Special Meeting Tuesday, January 29, 2013 at 8:30 a.m.--Compounding for Prescriber Use Consideration of Replacement Emergency Rule

4. Consideration of Replacement Emergency Rule re Compounding for Prescriber Use
Mr. Aron reminded the members of the disposition of their December 13, 2012 emergency rule and the January 18, 2013 legislative directive to issue a replacement emergency rule within two weeks. He reported the Regulation Revision Committee had met the previous week and prepared a regulatory proposal for a replacement emergency rule. Mr. Aron asked Mr. McKay, the committee chairman, to report on the committee’s meeting and proposal.
Mr. McKay reported the committee met on January 23 and that approximately twenty five guests were in attendance. He indicated the committee invited and received substantial input from the guests, which included a number of pharmacists practicing at several compounding pharmacies across the state. He directed the members to two documents in their meeting packet: the regulatory proposal developed by the committee, and a proposed declaration of emergency developed by staff. Following a brief discussion, Mr. McKay moved,
Resolved, that the Board approve the
Prior to the vote, Ms. Hall offered a clarifying amendment, which was approved without objection by the members. The motion for approval of the amended document was adopted after a unanimous roll call vote in the affirmative. Mr. McKay then directed the members to the regulatory proposal.
Declaration of Emergency – Compounding for Prescriber Use – LAC 46:LIII.2535.
In order to facilitate the discussion, Mr. McKay moved,
Resolved, that the Board approve Regulatory Proposal 2013-E-C ~ Compounding for Prescriber Use (Draft #1)
To authorize the Executive Director to submit the proposed amendment for promulgation upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process; and further, , to become effective as an Emergency Rule on January 31, 2013: and further,
To authorize the Executive Director to re-publish the Emergency Rule as may become necessary during the promulgation process.
During the discussion of that proposal, staff offered a suggested clarifying amendment within the paragraph relative to compounding commercial products not available. Mr. McKay moved to approve that clarifying amendment. The motion for approval of the clarifying amendment was adopted after a unanimous vote in the affirmative. Following additional discussion and comments from guests present, Mr. Aron called the question to a vote. The motion for approval of the amended regulatory proposal was adopted after a majority roll call vote in the affirmative. Mr. Adams, Mr. Bond, Mr. Burch, Mr. Dartez, and Mr. Valentine objected.
Following the vote, staff suggested a potential conflict in the interpretation of the regulatory proposal and the declaration of emergency. In particular, the regulatory proposal identified a limitation of ten percent of a pharmacy’s total dispensing and distribution activity, whereas the declaration of emergency identified a limitation of ten percent of a pharmacy’s compounding activity. The members reiterated their intent the

limitation should be applicable to a pharmacy’s entire dispensing and distribution activity and not just the compounding activity. Mr. Adams moved to direct the staff to prepare the appropriate amendment(s) for the declaration of emergency to reflect the language and intent of the regulatory proposal. That motion was adopted after a unanimous vote in the affirmative.
Source found here

Update on Status of Prescriber's Use in Louisiana

2013-1.2 ~ Compounding for Prescriber's Use  [Source: Regulatory Proposal 2013-E]
               01-29-2013     Board issued Declaration of Emergency & Emergency Rule, to become effective on 01-31-2013.
               01-30-2013     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.
               01-30-2013     Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.

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

Pursuant to First Report---waiting on summary of comments from public hearing on 2-27-13 and responses.

Reminder: Louisiana Board of Pharmacy Public Hearing Regarding Office or Prescriber's Use of Compound on Feb. 27, 2013

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

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