(A) This rule applies to compounded drugs products for human use.
(B) The following requirements do not apply to:
(1) A nuclear pharmacy that compounds radiopharmaceuticals. A radiopharmaceutical must be prepared pursuant to Chapter 4729-15 of the Administrative Code.
(C) For all non-sterile compounded drug products, the in-state pharmacy shall comply with the United States pharmacopeia chapter <795>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).
(D) For all sterile compounded drug products, the in-state pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).
(E) A pharmacist working at an in-state pharmacy as defined in rule 4729-16-01 of the Administrative Code licensed as a terminal distributor of dangerous drugs may compound and provide without a prescription a non-patient specific 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 4729.01 of the Revised Code and the following:
(1) 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.
(2) The in-state 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.
(F) The in-state pharmacy shall not supply more than a seventy-two hour supply of a non-patient specific compounded drug to a prescriber at a single location. A prescriber shall not have more than a seventy-two hour supply of a compounded drug at a single location at any given time. The seventy-two hour supply provided to the prescriber shall be determined by previous administration patterns provided by a 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 products for topical administration, pursuant to paragraphs ( E)(2)(b) and ( E)(2)(c) of this rule, shall be supplied to a prescriber in which the quantity does not exceed sixty grams or sixty milliliters at a single location. A prescriber shall not have more than sixty grams or sixty milliliters of a specific compounded drug at a single location at any given time; or
(2) Compounded non-sterile drug products intended to treat an emergency situation, pursuant to paragraph ( E)(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.
(G) The in-state pharmacy shall not sell a compounded drug to another pharmacy or wholesaler.
(H) Prescribers shall only administer a requested non-patient specific compounded drug directly to their own patients. Prescribers shall not:
(1) Dispense or personally furnish 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.
(I) The labeling of a compounded drug product 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;
(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;and
(11) The statement "Compounded Drug Product" or other similar statement.
(J) Compounded drug product containers that are too small to bear a complete label pursuant to paragraph ( I) 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), including all active ingredients;;
(5) The drug strength(s);
(6) The route of administration;
(7) The pharmacy control number;
(8) The pharmacy name.
(K) In all cases, a complete label meeting the requirements of paragraph (H) of this rule must be applied to the outside container in which such compounded product is supplied.
(L) The sale of a compounded drug product 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.
(M) A pharmacy shall follow the compounding requirements pursuant to rules 4729-16-03 and 4729-16-06 of the Administrative Code current professional compounding standards, and all applicable federal and state laws, rules, and regulations.
(N) No in-state pharmacy shall sell any amount of non-patient specific prescriber administered compounds for human use in excess of five per cent of the total amount of compounded drug products sold and/or dispensed from their pharmacy. The five per cent limitation shall be calculated on an annual basis and shall reference the number of dosage units. If the five per cent limitation is exceeded, then the pharmacy must apply to become an outsourcing facility pursuant to rule 4729-16-02 of the Administrative Code.
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.01, 4729.54, 4729.55, 4729.541
Prior Effective Dates: 5/1/2015