(A) Except as provided in divisions (B) to (D) of this section, all of the following are exempt from licensure as a terminal distributor of dangerous drugs:

Terms Used In Ohio Code 4729.541

  • Child: includes child by adoption. See Ohio Code 1.59
  • 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. See Ohio Code 4729.01

  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • Drug: means :

    (1) Any article recognized in the United States pharmacopoeia and national formulary, or any supplement to them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

    (2) Any other article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

    (3) Any article, other than food, intended to affect the structure or any function of the body of humans or animals;

    (4) Any article intended for use as a component of any article specified in division (E)(1), (2), or (3) of this section; but does not include devices or their components, parts, or accessories. See Ohio Code 4729.01

  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Person: includes any individual, partnership, association, limited liability company, or corporation, the state, any political subdivision of the state, and any district, department, or agency of the state or its political subdivisions. See Ohio Code 4729.01
  • prescriber: means an individual who is authorized by law to prescribe drugs or dangerous drugs or drug therapy related devices in the course of the individual's professional practice, including only the following:

    (1) A dentist licensed under Chapter 4715 of the Revised Code;

    (2) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner who holds a current, valid license issued under Chapter 4723 of the Revised Code to practice nursing as an advanced practice registered nurse;

    (3) A certified registered nurse anesthetist who holds a current, valid license issued under Chapter 4723 of the Revised Code to practice nursing as an advanced practice registered nurse, but only to the extent of the nurse's authority under sections 4723. See Ohio Code 4729.01

  • state: means the state of Ohio. See Ohio Code 1.59
  • Terminal distributor: includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist, licensed health professional authorized to prescribe drugs, or other person authorized by the state board of pharmacy. See Ohio Code 4729.01
  • United States: includes all the states. See Ohio Code 1.59

(1) A licensed health professional authorized to prescribe drugs;

(2) A business entity that is a corporation formed under division (B) of section 1701.03 of the Revised Code, a limited liability company formed under former Chapter 1705 of the Revised Code as that chapter existed prior to February 11, 2022, or Chapter 1706 of the Revised Code, or a professional association formed under Chapter 1785 of the Revised Code if the entity has a sole shareholder who is a prescriber and is authorized to provide the professional services being offered by the entity;

(3) A business entity that is a corporation formed under division (B) of section 1701.03 of the Revised Code, a limited liability company formed under former Chapter 1705 of the Revised Code as that chapter existed prior to February 11, 2022, or Chapter 1706 of the Revised Code, a partnership or a limited liability partnership formed under Chapter 1775 of the Revised Code, or a professional association formed under Chapter 1785 of the Revised Code, if, to be a shareholder, member, or partner, an individual is required to be licensed, certified, or otherwise legally authorized under Title XLVII of the Revised Code to perform the professional service provided by the entity and each such individual is a prescriber;

(4) An individual who holds a current license, certificate, or registration issued under Title XLVII of the Revised Code and has been certified to conduct diabetes education by a national certifying body specified in rules adopted by the state board of pharmacy under section 4729.68 of the Revised Code, but only with respect to insulin that will be used for the purpose of diabetes education and only if diabetes education is within the individual’s scope of practice under statutes and rules regulating the individual’s profession;

(5) An individual who holds a valid certificate issued by a nationally recognized S.C.U.B.A. diving certifying organization approved by the state board of pharmacy under rules adopted by the board, but only with respect to medical oxygen that will be used for the purpose of emergency care or treatment at the scene of a diving emergency;

(6) With respect to epinephrine autoinjectors that may be possessed under section 3313.7110, 3313.7111, 3314.143, 3326.28, or 3328.29 of the Revised Code, any of the following: the board of education of a city, local, exempted village, or joint vocational school district; a chartered or nonchartered nonpublic school; a community school established under Chapter 3314 of the Revised Code; a STEM school established under Chapter 3326 of the Revised Code; or a college-preparatory boarding school established under Chapter 3328 of the Revised Code;

(7) With respect to epinephrine autoinjectors that may be possessed under section 5101.76 of the Revised Code, any of the following: a residential camp, as defined in section 2151.011 of the Revised Code; a child day camp, as defined in section 5104.01 of the Revised Code; or a child day camp operated by any county, township, municipal corporation, township park district created under section 511.18 of the Revised Code, park district created under section 1545.04 of the Revised Code, or joint recreation district established under section 755.14 of the Revised Code;

(8) With respect to epinephrine autoinjectors that may be possessed under Chapter 3728 of the Revised Code, a qualified entity, as defined in section 3728.01 of the Revised Code;

(9) With respect to inhalers that may be possessed under section 3313.7113, 3313.7114, 3314.144, 3326.30, or 3328.30 of the Revised Code, any of the following: the board of education of a city, local, exempted village, or joint vocational school district; a chartered or nonchartered nonpublic school; a community school established under Chapter 3314 of the Revised Code; a STEM school established under Chapter 3326 of the Revised Code; or a college-preparatory boarding school established under Chapter 3328 of the Revised Code;

(10) With respect to inhalers that may be possessed under section 5101.77 of the Revised Code, any of the following: a residential camp, as defined in section 2151.011 of the Revised Code; a child day camp, as defined in section 5104.01 of the Revised Code; or a child day camp operated by any county, township, municipal corporation, township park district created under section 511.18 of the Revised Code, park district created under section 1545.04 of the Revised Code, or joint recreation district established under section 755.14 of the Revised Code;

(11) With respect to overdose reversal drugs that may be possessed for the purposes described in section 3715.50 of the Revised Code, any person or government entity exercising the authority conferred by that section;

(12) With respect to overdose reversal drugs that may be possessed for use in personally furnishing supplies of the drug pursuant to a protocol established under section 3715.503 of the Revised Code, any individual exercising the authority conferred by that section;

(13) With respect to injectable or nasally administered glucagon that may be possessed under sections 3313.7115, 3313.7116, 3314.147, 3326.60, and 3328.38 of the Revised Code, any of the following: the board of education of a city, local, exempted village, or joint vocational school district; a chartered or nonchartered nonpublic school; a community school established under Chapter 3314 of the Revised Code; a STEM school established under Chapter 3326 of the Revised Code; or a college-preparatory boarding school established under Chapter 3328 of the Revised Code;

(14) With respect to injectable or nasally administered glucagon that may be possessed under section 5101.78 of the Revised Code, any of the following: a residential camp, as defined in section 2151.011 of the Revised Code; a child day camp, as defined in section 5104.01 of the Revised Code; or a child day camp operated by any county, township, municipal corporation, township park district created under section 511.18 of the Revised Code, park district created under section 1545.04 of the Revised Code, or joint recreation district established under section 755.14 of the Revised Code;

(15) A facility that is owned and operated by the United States department of defense, the United States department of veterans affairs, or any other federal agency.

(B) If a person described in division (A) of this section is a pain management clinic or is operating a pain management clinic, the person shall hold a license as a terminal distributor of dangerous drugs with a pain management clinic classification issued under section 4729.552 of the Revised Code.

(C) If a person described in division (A) of this section is operating a facility, clinic, or other location described in division (B) of section 4729.553 of the Revised Code that must hold a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification, the person shall hold a license with that classification.

(D) Any of the persons described in divisions (A)(1) to (14) of this section shall hold a license as a terminal distributor of dangerous drugs in order to possess, have custody or control of, and distribute any of the following:

(1) Dangerous drugs that are compounded or used for the purpose of compounding;

(2) A schedule I, II, III, IV, or V controlled substance, as defined in section 3719.01 of the Revised Code.

Last updated January 27, 2023 at 3:29 PM

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