4729-16-01 Definitions.

(A) As used in this chapter of the Administrative Code:

(1) "Compounding", except as provided in paragraph (A) of rule 4729-16-04 of the Administrative Code, means the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, mixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance,

(2) "Cytotoxic" means a drug that has been shown to be carcinogenic or mutagenic to humans through active or passive exposure.

(3) "Drug" has the same meaning as division (E) of section 4729.01 of the Revised Code.

(4) "Drug shortage" means a drug on the United States food and drug administration's drug shortage list that 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 or wholesaler.

(5) "Fluid therapy pharmacy" means a pharmacy where the primary purpose is to compound and dispense parenteral compounded sterile product prescriptions.

(6) "Hazardous drugs" has the same meaning as defined in the United States pharmacopeia chapter chapter <800> USP 39 - NF 34, or any official supplement thereto (6/30/2016).

(7) "In-state health care facility" means any of the following that are licensed as a terminal distributor of dangerous drugs in the state of Ohio:

(a) A hospital registered with the department of health under section 3701.07 of the Revised Code;

(b) Ambulatory surgical facility as defined in section 3702.30 of the Revised Code; or

(c) Emergency medical service (EMS) organization as defined in section 4765.01 of the Revised Code.

(8) "In-state pharmacy" means any pharmacy, as defined in section 4729.01 of the Revised Code, located inside of Ohio that ships, mails, or delivers, in any manner, drugs at retail in or out of Ohio. An in-state pharmacy does not include a nuclear pharmacy as defined in rule 4729-15-01 of the Administrative Code.

(9) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as defined in division (I) of section 4729.01 of the Revised Code.

(10) "Medical director" means the physician who is responsible for managing and directing the provision of medical services at an in-state health care facility.

(11) "Non-resident pharmacy" means any pharmacy, as defined in section 4729.01 of the Revised Code, located outside of Ohio that ships, mails, or delivers, in any manner, drugs at retail into Ohio. A non-resident pharmacy does not include a nuclear pharmacy as defined in rule 4729-15-01 of the Administrative Code.

(12) "Non-sterile compounded drug" means a drug preparation intended to be non-sterile.

(13) "Outsourcing facility" means a facility at one geographic location or address that is engaged in anticipatory compounding of sterile drugs and complies with the United States food and drug administration section 503B of the Federal Food, Drug, and Cosmetic Act (11/27/2013).

(14) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin.

(15) "Sterile" means a dosage form free of living microorganisms (aseptic)

(16) "Sterile compounded drug" means a preparation intended to be sterile.

(17) "Verified Pharmacy Program" means a program operated by the national association of boards of pharmacy that conducts inspections of pharmacies.

(18) "Licensed personnel approved by the responsible person" as used in paragraph (J) of rule 4729-16-04 and paragraph (G) of rules 4729-16-11 and 4729-16-13 of the Administrative Code means individuals licensed or registered pursuant to Chapters 4723., 4729., 4730., and 4731. of the Revised Code.

(19) "Beyond use date" means the date or time after which a compounded drug product shall not be administered, stored or transported. The date is determined from the date and time the preparation is compounded.

Effective: 4/1/2017
Five Year Review (FYR) Dates: 10/24/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.01
Prior Effective Dates: 10/24/2014, 5/1/15