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

West Virginia Pharmacy Practice Act Receives Makeover with New Practice Act Entitled The Larry W. Border Pharmacy Practice Act

New Practice Act Entitled ‘The Larry W.
Border Pharmacy Practice Act’
The West Virginia Pharmacy Practice Act received a makeover
during the 2013 Regular Legislative Session. The legislature
passed House Bill 2577 on April 13, 2013, setting an
effective date of July 1, 2013. At the time of this writing, the
bill was among the many pieces of legislation that passed that
have to be painstakingly reviewed by the Governor’s Office
as he decides whether to sign them or not. The West Virginia
Board of Pharmacy has been informed that Governor Earl Ray
Tomblin plans to sign the bill, so it will become law, effective
at the beginning of July. If for some reason the bill does get
vetoed, then you can stop reading here . . . that is, unless you
just love the Newsletter so much that you want to see what the
Board would have had to say about it anyway.


continue reading in West Virginia Board of Pharmacy June 2013 Newsletter

Contaminated Compounded Steroid Infects 13 Floridians By Jennifer Wolack, // June 1, 2013

watch video and read story here

American Pharmacy Association Comments on Senate Bill (Pharmaceutical Compounding Quality and Accountability Act

June 01, 2013

APhA comments on Senate draft proposal

The Senate Health, Education, Labor, & Pensions (HELP) Committee on May 15 introduced the Pharmaceutical Compounding Quality and Accountability Act (S. 959) following a full committee hearing and comments from stakeholders, such as APhA, on an April 26 draft proposal.

The Senate compounding bill—a manager’s mark, or updated bill, was released May 20—would draw a line between traditional compounders, which would be regulated primarily by state boards of pharmacy, and “compounding manufacturers,” which would be regulated by FDA; compounding manufacturers would be defined as those that make sterile products without or before a prescription and sell those products across state lines. Pharmacies within health systems would remain regulated as traditional compounders. Compounding manufacturers could not be licensed as pharmacies.

Compounding manufacturers would register with FDA, make products under a pharmacist’s oversight and in compliance with Good Manufacturing Practices, and pay an annual establishment fee to defray the cost of FDA oversight such as inspections and a reinspection fee as needed; small businesses would pay reduced fees.

Traditional compounders would be prohibited from compounding marketed FDA-approved drugs not in shortage, variations of marketed FDA-approved drugs unless they fulfill a specific patient need, or products subject to certain Risk Evaluation and Mitigation Strategies unless it is to fulfill a specific patient need and the compounder uses comparable safety controls. The compounding of certain drugs demonstrably difficult to compound, such as complex dosage forms and biologics, could be prohibited through regulatory rulemaking with comments. Wholesale distribution of compounded products would not be permitted. Marketing of compounded drugs could not be false or misleading.

The Senate compounding bill also would encourage communication among FDA and the states as well as among the states themselves. For more information on the bill, visit the HELP Committee website (www.help.senate.gov).

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