4729-9-01 Definitions.

(A) "Dangerous drug," as defined in section 4729.01 of the Revised Code, means any drug or drug product whose commercial package bears a label containing the symbol "Rx only", the legend "Caution: Federal Law Prohibits Dispensing Without Prescription" or "Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian," or any similar restrictive statement.

(B) "Adulterated drug" means a dangerous drug that is beyond the expiration date as stated by the manufacturer, packer, or distributor in its labeling or if it is not stored or dispensed according to the requirement of the federal act as indicated in the product labeling. This does not apply to expired drugs that are donated pursuant to sections 3715.88 to 3715.92 of the Revised Code. A compounded dangerous drug is considered adulterated if it exceeds:

(1) The beyond use date as indicated in United States pharmacopeia chapters <795> and <797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015); or

(2) The beyond use date if prepared strictly in accordance with manufacturers' product labeling as specified in that labeling or from appropriate literature sources or direct testing.

(C) "Psychiatric outpatient facility" means a facility where psychiatric evaluation and treatment is provided on an outpatient basis.

(D) As used in Chapters 3719. and 4729. of the Revised Code, "registered" and "licensed" mean that an individual or facility has met the initial qualifications for registration and licensure with the state board of pharmacy and, if they are still actively practicing pharmacy or distributing drugs, have complied with annual renewal procedures, including payment of applicable fees.

(E) "Revoke", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license rendering such license void and such license may not be reissued. "Revoke" is an action that is permanent against the license and licensee.

(F) "Suspend", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license rendering such license without force and effect for a period of time as determined by the state board of pharmacy. The board may require that an individual whose license has been suspended may not be employed by or work in a facility licensed by the state board of pharmacy to possess or distribute dangerous drugs during such period of suspension.

(G) "Summary suspension", as used in Chapters 3719. and 4729. of the Revised Code, means to take immediate action against a license, registration or identification card without a prior hearing rendering such license without force and effect for a period of time as indicated in section 3719.031, 3719.121 or 4729.571 of the Revised Code. The board may suspend a license, registration or identification card issued pursuant to Chapters 3719. and 4729. of the Revised Code by utilizing a telephone conference call to review the allegations and take a vote.

(H) "Place on probation", as used in Chapter 4729. of the Revised Code, means to take action against a license suspending some or all of the sanctions imposed by the board against that license. The terms of the probation shall state the period of time covered by the probation and may include other conditions as determined by the state board of pharmacy.

(I) "Refuse to grant or renew", as used in Chapter 4729. of the Revised Code, means to deny original or continued licensure for a period of at least twelve months. After twelve months or such period of time as the individual board order may require, a pharmacist, a pharmacy intern, a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, a wholesaler of controlled substances, a manufacturer of controlled substances, or an individual or facility who desires to attain such status by licensure, and whose license the state board of pharmacy has refused to grant or renew, may make application to the board for issuance of a new license. A pharmacist, or an individual who desires to attain such status by licensure, whose license the state board of pharmacy has refused to grant or renew must meet any requirements established by the board or must pass any examination required by the board.

(J) "Campus", as used to describe a type of terminal distributor of dangerous drugs license issued pursuant to division (E) of section 4729.51 of the Revised Code, means an establishment or place consisting of multiple buildings where dangerous drugs are stored that are located on a contiguous plot of land. All such buildings and stocks of dangerous drugs shall be under common ownership and control.

(K) "Certified diabetes educator", as used in Chapters 3719. and 4729. of the Revised Code, means a person who has been certified to conduct diabetes education by the "National Certification Board for Diabetes Educators (NCBDE)."

(L) "Abandoned application" means an application for a terminal or wholesale distributor of dangerous drugs where the applicant fails to complete all application requirements within thirty days after being notified by the board. An applicant forfeits all fees associated with an abandoned application. The board shall not be required to act on any abandoned application and the application may be destroyed by board staff. If the application is abandoned, the applicant shall be required to reapply for licensure, submit the required fee and comply with the licensing requirements in effect at the time of reapplication.

Effective: 4/28/2016
Five Year Review (FYR) Dates: 01/21/2016 and 12/01/2020
Promulgated Under: 119.03
Statutory Authority: 3715.91, 3719.28, 4729.26
Rule Amplifies: 3715.88, 3715.89, 3715.90, 3715.92, 3719.01, 3719.03, 4729.01, 4729.16, 4729.56, 4729.57
Prior Effective Dates: 1/1/63, 2/15/82, 3/21/88, 7/1/91, 7/1/92, 1/17/97, 2/1/98, 3/1/99, 1/1/01, 1/1/09