COMPOUNDING IN OHIO
We recognize and enforce Federal law that compounding is performed by a pharmacist in a
pharmacy and pursuant to a patient specific prescription. Refer to 21 USCA 353a
You may not compound FDA approved drugs that are commercially available.
On July 9, 2012, President Obama signed into law the FDA Safety and Innovation
Act which in part grants permission for hospitals and health systems to repack and
share drugs, not controlled substances, in short supply during an FDA published
shortage plus 60 days after the drug is taken off the list. Caveat: only within the
same health system
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/Significant
AmendmentstotheFDCAct/FDASIA/ucm313121.htm
Our state law defines compounding in ORC 4729.01(C)
(C) “Compounding” means the preparation, mixing, assembling, packaging, and
labeling of one or more drugs in any of the following circumstances:
(1) Pursuant to a prescription issued by a licensed health professional authorized
to prescribe drugs;
(2) Pursuant to the modification of a prescription made in accordance with a
consult agreement;
(3) As an incident to research, teaching activities, or chemical analysis;
(4) In anticipation of orders for drugs pursuant to prescriptions, based on routine,
regularly observed dispensing patterns;
(5) Pursuant to a request made by a licensed health professional authorized to
prescribe drugs for a drug that is to be used by the professional for the purpose
of direct administration to patients in the course of the professional’s practice,
if all of the following apply:
(a) At the time the request is made, the drug is not commercially available
regardless of the reason that the drug is not available, including the
absence of a manufacturer for the drug or the lack of a readily available
supply of the drug from a manufacturer.
(b) A limited quantity of the drug is compounded and provided to the
professional.Compounding in Ohio
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(c) The drug is compounded and provided to the professional as an
occasional exception to the normal practice of dispensing drugs pursuant
to patient-specific prescriptions.
Note: also refer to OAC 4729-9-25 below for specifics relating to (5)
We further regulate compounding in the following rules:
DRUGS COMPOUNDED IN A PHARMACY OAC Rule 4729-9-21
Please review particularly:
(F) A prescription shall be compounded and dispensed only pursuant to a
specific order for an individual patient issued by a prescriber. A
limited quantity may be compounded in anticipation of prescription drug
orders based on routine, regularly observed prescribing patterns.
(G) A compounded prescription that is dispensed to a patient must be
labeled according to rule 4729-5-16 of the Administrative Code.
DRUGS COMPOUNDED FOR DIRECT ADMINISTRATION BY A PRESCRIBER
OAC Rule 4729-9-25
Please review particularly:
A pharmacist may compound a drug pursuant to a request made by a
prescriber, or by an agent of the prescriber, for a drug to be used by the
prescriber for the purpose of the direct administration to patients in the
course of the prescriber's practice pursuant to division (C)(5) of section
4729.01of the Revised Code and the following:
(A) The drug is compounded and provided to a prescriber as an occasional
exception to the normal practice of dispensing drugs pursuant to patient
specific prescriptions:
(1) A pharmacy may provide compounded drug preparations to
prescribers for direct administration to patients as long as the total
value of those compounded preparations does not exceed five percent
of the pharmacy's total dollar amount of sales of patient specific
compounded prescriptions within the past twelve months.
(2) The pharmacy shall only provide those compounded drugs that are
not commercially available to a prescriber which are needed:
(a) To treat an emergency situation;
(b) For an unanticipated procedure for which a time delay would
negatively affect a patient outcome;
(c) For diagnostic purposes.
(B) A pharmacy shall not supply more than a seventy-two hour supply of a
compounded drug to a prescriber. A prescriber shall not have more than
a seventy-two hour supply of a compounded drug on hand at any given
time. The seventy-two hour supply provided to the prescriber shall be
determined by previous administration patterns provided by a Compounding in Ohio
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prescriber to the pharmacist. The limitation of a seventy-two hour
supply shall not apply to either of the following:
(1) Compounded non-sterile drug preparations for topical administration,
pursuant to paragraphs (A)(2)(b) and (A)(2)(c) of this rule, shall be
supplied to a prescriber in a single container in which the quantity
does not exceed sixty grams or sixty milliliters. A prescriber shall not
have more than one full container of sixty grams or sixty milliliters of
a compounded drug on hand at any given time; or
(2) Compounded non-sterile drug preparations intended to treat an
emergency situation, pursuant to paragraph (A)(2)(a) of this rule, may
be provided to a prescriber in a quantity required to sufficiently treat
individuals in the event of an emergency situation.
(C) A pharmacy shall not sell a compounded drug to another pharmacy
or wholesaler.
(D) Prescribers shall only administer a requested compounded drug directly
to their own patients. Prescribers shall not:
(1) Dispense a compounded drug to a patient;
(2) Sell a compounded drug to another prescriber;
(3) Sell a compounded drug to a pharmacy; or
(4) Return a compounded drug to the supplying pharmacy.
(E) Compounded drug preparations shall be assigned beyond use dates
that are based on stability and sterility for sterile compounded drug
preparations and stability for non-sterile compounded drug preparations
pursuant to the following:
(1) Beyond use dates for non-sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards; by published peer
reviewed pharmaceutical literature that have been critically reviewed
by unbiased independent experts; or in compliance with requirements
in the current edition of an official compendium, such as the "United
States Pharmacopoeia/National Formulary".
(2) Beyond use dates for sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards or shall be based on
the following "United States Pharmacopoeia/National Formulary"
standards:
(a) Low risk level compounded drug preparations shall be assigned a
beyond use date of not more than forty-eight hours when stored
at controlled room temperature at twenty to twenty-five degrees
celsius, or fourteen days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(b) Medium risk level compounded drug preparations shall be
assigned a beyond use date of not more than thirty hours when
stored at controlled room temperature at twenty to twenty-five
degrees celsius, or nine days when refrigerated at two to eight Compounding in Ohio
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degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(c) High risk level compounded drug preparations shall be assigned
a beyond use date of not more than twenty-four hours when
stored at controlled room temperature at, twenty to twenty-five
degrees celsius, or three days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(F) The labeling of a compounded drug preparation must contain the
following:
(1) The statement "For direct patient administration only" displayed
prominently;
(2) The statement "Not for resale" displayed prominently;
(3) Proper storage conditions;
(4) Beyond use dates pursuant to paragraph (E) of this rule;
(5) The name(s) of the active and inactive ingredients;
(6) The amount or percentage of active drug ingredients;
(7) The quantity of compounded drug provided;
(8) The route of administration;
(9) The pharmacy name, address, and telephone number;
(10) The pharmacy control number assigned to the compounded drug
preparation.
(G) Compounded drug preparation containers that are too small to bear a
complete label pursuant to paragraph (F) of this rule must bear a label
that contains at least the following information:
(1) "Not for resale";
(2) The storage conditions if other than room temperature;
(3) The beyond use date;
(4) The drug name(s);
(5) The drug strength;
(6) The route of administration;
(7) The pharmacy control number;
(8) The pharmacy name.
In all cases, a complete label meeting the requirements of paragraph (F)
of this rule must be applied to the outside container in which such
compounded preparation is supplied.
(H) The sale of a compounded drug preparation to a prescriber is
considered a wholesale sale as defined in section 4729.01 of the
Revised Code. A pharmacy is required to follow the record keeping
requirements for wholesale sales listed in paragraph (H) of rule 4729-9-
16 of the Administrative Code.
(I) A pharmacy must follow the compounding requirements pursuant to
rules 4729-5-25 and 4729-9-21 of the Administrative Code, Chapter
4729-19 of the Administrative Code, current professional
compounding standards, and all applicable federal and state laws,
rules, and regulations.Compounding in Ohio
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In addition, all prescriptions must be sent to the PATIENT
If you want to ship ANY patient specific medications to the prescriber rather than the patient,
you must have Board approval (specific to each prescriber office/pharmacy) prior to any such
shipment pursuant to
PRESCRIPTION PICK-UP STATION OAC Rule 4729-5-10
Please review particularly:
(B) No pharmacist shall dispense dangerous drugs to a place which offers, in
any manner, its services as a "pick-up station" or intermediary for the
purpose of having prescriptions filled or delivered unless such place is a
pharmacy as defined in section 4729.01 of the Revised Code, has
received board approval to function in such a manner, and paragraphs
(B)(1) to (B)(4) of this rule apply or, if not a pharmacy, unless all of the
following apply:
(1) The site is appropriately licensed pursuant to Chapter 4729. of the
Revised Code.
(2) The receipt, storage, control, and distribution of prescriptions or
drugs are in the full and actual charge of a health care professional
licensed pursuant to Chapter 4715., 4723., 4729., 4730., 4731., or
4741. of the Revised Code.
(3) An appropriate recordkeeping system is in place that will provide
accountability for proper receipt, delivery, and return of all
prescription medications.
(4) There is a documented method in place to ensure compliance with
rule 4729-5-22 of the Administrative Code.
(5) The state board of pharmacy has approved the site for such activity
due to clear and convincing evidence that delivery of prescription
medication directly to the patient would result in:
(a) Danger to public health or safety, or
(b) Danger to the patient without increased involvement by a health
care professional in the patient’s drug therapy.
If your special circumstance meets these criteria, you must request approval to ship to a
pick-up station rather than to the patient using the request form that is available on our
website
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