As Introduced                            1            

123rd General Assembly                                             4            

   Regular Session                                 S. B. No.  248  5            

      1999-2000                                                    6            


                          SENATOR DRAKE                            8            


_________________________________________________________________   10           

                          A   B I L L                                           

             To amend section 4729.01 and to enact section         12           

                4729.41 of the Revised Code to permit a            13           

                pharmacist who has completed a course in drug      14           

                administration approved by the State Board of                   

                Pharmacy to administer drugs.                      15           




BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:        17           

      Section 1.  That section 4729.01 be amended and section      19           

4729.41 of the Revised Code be enacted as follows:                 20           

      Sec. 4729.01.  As used in this chapter:                      29           

      (A)  "Pharmacy," except when used in a context that refers   31           

to the practice of pharmacy, means any area, room, rooms, place    32           

of business, department, or portion of any of the foregoing where  34           

the practice of pharmacy is conducted.                             36           

      (B)  "Practice of pharmacy" means providing pharmacist care  38           

requiring specialized knowledge, judgment, and skill derived from  40           

the principles of biological, chemical, behavioral, social,        41           

pharmaceutical, and clinical sciences.  As used in this division,  42           

"pharmacist care" includes the following:                                       

      (1)  Interpreting prescriptions;                             44           

      (2)  Compounding or dispensing drugs and dispensing drug     46           

therapy related devices;                                           47           

      (3)  Counseling individuals with regard to their drug        49           

therapy, recommending drug therapy related devices, and assisting  51           

in the selection of drugs and appliances for treatment of common   52           

diseases and injuries and providing instruction in the proper use  54           

of the drugs and appliances;                                                    

                                                          2      


                                                                 
      (4)  Performing drug regimen reviews with individuals by     57           

discussing all of the drugs that the individual is taking and                   

explaining the interactions of the drugs;                          58           

      (5)  Performing drug utilization reviews with licensed       60           

health professionals authorized to prescribe drugs when the        61           

pharmacist determines that an individual with a prescription has   62           

a drug regimen that warrants additional discussion with the        63           

prescriber;                                                        64           

      (6)  Advising an individual and the health care              66           

professionals treating an individual with regard to the            67           

individual's drug therapy;                                         68           

      (7)  Acting pursuant to a consult agreement with a           70           

physician authorized under Chapter 4731. of the Revised Code to    74           

practice medicine and surgery or osteopathic medicine and          75           

surgery, if an agreement has been established with the physician;  76           

      (8)  IF A PHARMACIST LICENSED UNDER THIS CHAPTER HAS MET     78           

THE REQUIREMENTS OF SECTION 4729.41 OF THE REVISED CODE,           79           

ADMINISTERING DRUGS PRESCRIBED BY A LICENSED HEALTH PROFESSIONAL   80           

AUTHORIZED TO PRESCRIBE DRUGS.                                     81           

      (C)  "Compounding" means the preparation, mixing,            84           

assembling, packaging, and labeling of one or more drugs in any    85           

of the following circumstances:                                    86           

      (1)  Pursuant to a prescription issued by a licensed health  89           

professional authorized to prescribe drugs;                                     

      (2)  Pursuant to the modification of a prescription made in  91           

accordance with a consult agreement;                               92           

      (3)  As an incident to research, teaching activities, or     95           

chemical analysis;                                                              

      (4)  In anticipation of prescription drug orders based on    98           

routine, regularly observed dispensing patterns.                                

      (D)  "Consult agreement" means an agreement to manage an     100          

individual's drug therapy that has been entered into by a          102          

pharmacist and a physician authorized under Chapter 4731. of the   103          

Revised Code to practice medicine and surgery or osteopathic       106          

                                                          3      


                                                                 
medicine and surgery.                                                           

      (E)  "Drug" means:                                           108          

      (1)  Any article recognized in the United States             110          

pharmacopoeia and national formulary, or any supplement to them,   112          

intended for use in the diagnosis, cure, mitigation, treatment,    113          

or prevention of disease in humans or animals;                     114          

      (2)  Any other article intended for use in the diagnosis,    116          

cure, mitigation, treatment, or prevention of disease in humans    118          

or animals;                                                                     

      (3)  Any article, other than food, intended to affect the    120          

structure or any function of the body of humans or animals;        122          

      (4)  Any article intended for use as a component of any      124          

article specified in division (C)(1), (2), or (3) of this          125          

section; but does not include devices or their components, parts,  126          

or accessories.                                                    127          

      (F)  "Dangerous drug" means any of the following:            129          

      (1)  Any drug to which either of the following applies:      131          

      (a)  Under the "Federal Food, Drug, and Cosmetic Act," 52    134          

Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is        135          

required to bear a label containing the legend "Caution:  Federal  137          

law prohibits dispensing without prescription" or "Caution:        138          

Federal law restricts this drug to use by or on the order of a     139          

licensed veterinarian" or any similar restrictive statement, or    140          

the drug may be dispensed only upon a prescription;                141          

      (b)  Under Chapter 3715. or 3719. of the Revised Code, the   143          

drug may be dispensed only upon a prescription.                    144          

      (2)  Any drug that contains a schedule V controlled          146          

substance and that is exempt from Chapter 3719. of the Revised     147          

Code or to which that chapter does not apply;                      148          

      (3)  Any drug intended for administration by injection into  150          

the human body other than through a natural orifice of the human   151          

body.                                                              152          

      (G)  "Federal drug abuse control laws" has the same meaning  154          

as in section 3719.01 of the Revised Code.                         155          

                                                          4      


                                                                 
      (H)  "Prescription" means a written, electronic, or oral     160          

order for drugs or combinations or mixtures of drugs to be used    161          

by a particular individual or for treating a particular animal,    162          

issued by a licensed health professional authorized to prescribe   165          

drugs.                                                                          

      (I)  "Licensed health professional authorized to prescribe   168          

drugs" or "prescriber" means an individual who is authorized by    170          

law to prescribe drugs or dangerous drugs or drug therapy related  174          

devices in the course of the individual's professional practice,   175          

including only the following:                                      176          

      (1)  A dentist licensed under Chapter 4715. of the Revised   179          

Code;                                                                           

      (2)  An advanced practice nurse approved under section       182          

4723.56 of the Revised Code to prescribe drugs and therapeutic     183          

devices;                                                           184          

      (3)  An optometrist licensed under Chapter 4725. of the      187          

Revised Code to practice optometry under a therapeutic             190          

pharmaceutical agents certificate;                                              

      (4)  A physician authorized under Chapter 4731. of the       193          

Revised Code to practice medicine and surgery, osteopathic         196          

medicine and surgery, or podiatry;                                              

      (5)  A veterinarian licensed under Chapter 4741. of the      198          

Revised Code.                                                      199          

      (J)  "Sale" and "sell" include delivery, transfer, barter,   201          

exchange, or gift, or offer therefor, and each such transaction    202          

made by any person, whether as principal proprietor, agent, or     203          

employee.                                                          204          

      (K)  "Wholesale sale" and "sale at wholesale" mean any sale  206          

in which the purpose of the purchaser is to resell the article     207          

purchased or received by the purchaser.                            208          

      (L)  "Retail sale" and "sale at retail" mean any sale other  210          

than a wholesale sale or sale at wholesale.                        211          

      (M)  "Retail seller" means any person that sells any         213          

dangerous drug to consumers without assuming control over and      214          

                                                          5      


                                                                 
responsibility for its administration.  Mere advice or             215          

instructions regarding administration do not constitute control    216          

or establish responsibility.                                       217          

      (N)  "Price information" means the price charged for a       219          

prescription for a particular drug product and, in an easily       220          

understandable manner, all of the following:                       221          

      (1)  The proprietary name of the drug product;               223          

      (2)  The established (generic) name of the drug product;     225          

      (3)  The strength of the drug product if the product         227          

contains a single active ingredient or if the drug product         228          

contains more than one active ingredient and a relevant strength   229          

can be associated with the product without indicating each active  230          

ingredient.  The established name and quantity of each active      231          

ingredient are required if such a relevant strength cannot be so   232          

associated with a drug product containing more than one            233          

ingredient.                                                        234          

      (4)  The dosage form;                                        236          

      (5)  The price charged for a specific quantity of the drug   238          

product.  The stated price shall include all charges to the        239          

consumer, including, but not limited to, the cost of the drug      240          

product, professional fees, handling fees, if any, and a           241          

statement identifying professional services routinely furnished    242          

by the pharmacy.  Any mailing fees and delivery fees may be        243          

stated separately without repetition.  The information shall not   244          

be false or misleading.                                            245          

      (O)  "Wholesale distributor of dangerous drugs" means a      247          

person engaged in the sale of dangerous drugs at wholesale and     248          

includes any agent or employee of such a person authorized by the  250          

person to engage in the sale of dangerous drugs at wholesale.      251          

      (P)  "Manufacturer of dangerous drugs" means a person,       253          

other than a pharmacist, who manufactures dangerous drugs and who  254          

is engaged in the sale of those dangerous drugs within this        255          

state.                                                             256          

      (Q)  "Terminal distributor of dangerous drugs" means a       258          

                                                          6      


                                                                 
person who is engaged in the sale of dangerous drugs at retail,    260          

or any person, other than a wholesale distributor or a             261          

pharmacist, who has possession, custody, or control of dangerous   263          

drugs for any purpose other than for that person's own use and     265          

consumption, and includes pharmacies, hospitals, nursing homes,    266          

and laboratories and all other persons who procure dangerous       267          

drugs for sale or other distribution by or under the supervision   268          

of a pharmacist or licensed health professional authorized to      269          

prescribe drugs.                                                                

      (R)  "Promote to the public" means disseminating a           271          

representation to the public in any manner or by any means, other  272          

than by labeling, for the purpose of inducing, or that is likely   273          

to induce, directly or indirectly, the purchase of a dangerous     274          

drug at retail.                                                    275          

      (S)  "Person" includes any individual, partnership,          277          

association, limited liability company, or corporation, the        278          

state, any political subdivision of the state, and any district,   279          

department, or agency of the state or its political subdivisions.  280          

      (T)  "Finished dosage form" has the same meaning as in       282          

section 3715.01 of the Revised Code.                               283          

      (U)  "Generically equivalent drug" has the same meaning as   285          

in section 3715.01 of the Revised Code.                            286          

      (V)  "Animal shelter" means a facility operated by a humane  288          

society or any society organized under Chapter 1717. of the        289          

Revised Code or a dog pound operated pursuant to Chapter 955. of   290          

the Revised Code.                                                  291          

      (W)  "Food" has the same meaning as in section 3715.01 of    294          

the Revised Code.                                                               

      (X)  "ADMINISTER" HAS THE SAME MEANING AS IN SECTION         296          

3719.01 OF THE REVISED CODE.                                       297          

      Sec. 4729.41.  A PHARMACIST LICENSED UNDER THIS CHAPTER WHO  299          

HAS SUCCESSFULLY COMPLETED A COURSE APPROVED BY THE STATE BOARD    300          

OF PHARMACY IN ADMINISTRATION OF DRUGS MAY ADMINISTER DRUGS        301          

PRESCRIBED BY A LICENSED HEALTH PROFESSIONAL AUTHORIZED TO         302          

                                                          7      


                                                                 
PRESCRIBE DRUGS.  PROOF OF SUCCESSFULLY COMPLETING THE COURSE      303          

SHALL BE MAINTAINED BY THE PHARMACIST AT THE PHARMACIST'S PLACE    304          

OF EMPLOYMENT, SUBJECT TO INSPECTION BY THE BOARD OR THE BOARD'S   305          

DESIGNEE.                                                                       

      THE BOARD SHALL APPROVE COURSES FOR THE PURPOSES OF THIS     307          

SECTION.                                                                        

      Section 2.  That existing section 4729.01 of the Revised     309          

Code is hereby repealed.                                           310