Board Rules for Compounding Reemphasized
In the wake of the tragic events causing harm and loss of life across
the country, including several deaths in Tennessee, due to the fungal
meningitis outbreak, it is important to review the current definitions
and rules for Tennessee-licensed pharmacies practicing the art of
compounding.
To start this discussion, it is important to understand the difference
between compounding and manufacturing. Refer to the following
definitions:
Tennessee Code Ann. §63-10-204 Definitions.
(4) “Compounding” means the preparation, mixing, assembling, packaging or labeling of a drug or device:
(A) As the result of a prescription order or initiative based on
the prescriber-patient-pharmacist relationship in the course
of professional practice;
(B) In anticipation of prescription orders based on routine,
regularly observed prescribing patterns; or
(C) For the purpose of, or as an incident to, research, teaching
or chemical analysis and not for sale or dispensing;
(12) “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 by or pursuant to the lawful order of a prescriber;
(21) “Manufacturer” means any person, except a pharmacist
compounding in the normal course of professional practice,
engaged in the commercial production, preparation, propagation, conversion or processing of a drug, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical synthesis, or both, and
includes any packaging or repackaging of a drug or the labeling
or relabeling of its container and the promotion and marketing
of such drugs or devices;
(13) “Distribute” means the delivery of a drug or device, other
than by administering or dispensing, to persons other than the
patient or the patient’s agent;
Therefore, be advised that the patient-specific prescription via the
prescriber-patient-pharmacist (also known as the three-legged stool)
is required for the pharmacist to prepare and dispense a compounded
prescription.
To sell a manufactured drug without a prescription in Tennessee, (ie, office or hospital use) a wholesaler/manufacturer/distributor
(W/M/D) license, issued by the Tennessee Board of Pharmacy, is
required as discussed in the July 27-28, 2011 Board meeting minutes:
A company with the business model of providing admixture
pharmacy services, appeared before the board to ask for permission to operate as a pharmacy in Tennessee. The representative
explained that the company would compound sterile preparation in anticipation of institutional pharmacies’ prescription
orders and it would be based on the institution prescriber’s
routine prescribing patterns. The compounded admixture is
not patient specific but the company would like to send the
admixture to institutions based on past usage of the product.
After discussion, a member of the Board made the motion that
based on the business model discussed with this company, it
would be necessary that they be licensed in Tennessee as a
manufacturer/wholesaler/distributor. Furthermore, the motion
stated that if they decided to dispense patient specific, they
would have to be licensed as a pharmacy as well. The motion
was seconded and carried.
Currently, there are pharmacies licensed by the Board that carry
both W/M/D and pharmacy licenses. However, be advised that Food
and Drug Administration and Drug Enforcement Administration
(DEA) regulations may require licensure or other certifications to also
manufacture drug products for sale, purchase, or transfer.
For pharmacists practicing the art of sterile compounding under a
pharmacy license for patient-specific prescriptions, it is advised
to review the current Tennessee Board of Pharmacy rules found at
the following Web link: www.state.tn.us/sos/rules/1140/1140-07
.pdf. Board rules require documentation to be completed and readily
available, including flow hood certification, pre-filter records, training,
and policies and procedures
http://health.state.tn.us/Boards/Pharmacy/index.shtml
December 2012
In the wake of the tragic events causing harm and loss of life across
the country, including several deaths in Tennessee, due to the fungal
meningitis outbreak, it is important to review the current definitions
and rules for Tennessee-licensed pharmacies practicing the art of
compounding.
To start this discussion, it is important to understand the difference
between compounding and manufacturing. Refer to the following
definitions:
Tennessee Code Ann. §63-10-204 Definitions.
(4) “Compounding” means the preparation, mixing, assembling, packaging or labeling of a drug or device:
(A) As the result of a prescription order or initiative based on
the prescriber-patient-pharmacist relationship in the course
of professional practice;
(B) In anticipation of prescription orders based on routine,
regularly observed prescribing patterns; or
(C) For the purpose of, or as an incident to, research, teaching
or chemical analysis and not for sale or dispensing;
(12) “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 by or pursuant to the lawful order of a prescriber;
(21) “Manufacturer” means any person, except a pharmacist
compounding in the normal course of professional practice,
engaged in the commercial production, preparation, propagation, conversion or processing of a drug, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical synthesis, or both, and
includes any packaging or repackaging of a drug or the labeling
or relabeling of its container and the promotion and marketing
of such drugs or devices;
(13) “Distribute” means the delivery of a drug or device, other
than by administering or dispensing, to persons other than the
patient or the patient’s agent;
Therefore, be advised that the patient-specific prescription via the
prescriber-patient-pharmacist (also known as the three-legged stool)
is required for the pharmacist to prepare and dispense a compounded
prescription.
To sell a manufactured drug without a prescription in Tennessee, (ie, office or hospital use) a wholesaler/manufacturer/distributor
(W/M/D) license, issued by the Tennessee Board of Pharmacy, is
required as discussed in the July 27-28, 2011 Board meeting minutes:
A company with the business model of providing admixture
pharmacy services, appeared before the board to ask for permission to operate as a pharmacy in Tennessee. The representative
explained that the company would compound sterile preparation in anticipation of institutional pharmacies’ prescription
orders and it would be based on the institution prescriber’s
routine prescribing patterns. The compounded admixture is
not patient specific but the company would like to send the
admixture to institutions based on past usage of the product.
After discussion, a member of the Board made the motion that
based on the business model discussed with this company, it
would be necessary that they be licensed in Tennessee as a
manufacturer/wholesaler/distributor. Furthermore, the motion
stated that if they decided to dispense patient specific, they
would have to be licensed as a pharmacy as well. The motion
was seconded and carried.
Currently, there are pharmacies licensed by the Board that carry
both W/M/D and pharmacy licenses. However, be advised that Food
and Drug Administration and Drug Enforcement Administration
(DEA) regulations may require licensure or other certifications to also
manufacture drug products for sale, purchase, or transfer.
For pharmacists practicing the art of sterile compounding under a
pharmacy license for patient-specific prescriptions, it is advised
to review the current Tennessee Board of Pharmacy rules found at
the following Web link: www.state.tn.us/sos/rules/1140/1140-07
.pdf. Board rules require documentation to be completed and readily
available, including flow hood certification, pre-filter records, training,
and policies and procedures
http://health.state.tn.us/Boards/Pharmacy/index.shtml
December 2012
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