Sub.
S.B. 18
126th General Assembly
(As Passed by the General Assembly)
Sens. Wachtmann, Austria, Spada, Dann
Reps. Reidelbach, Seaver, White, Barrett, Buehrer, Collier, Combs, C. Evans, Flowers, Gibbs, Hughes, Miller, Schneider, Seitz, Setzer, G. Smith, J. Stewart, Trakas, Yates
Effective date: *
ACT SUMMARY
· Permits a pharmacist to compound a limited quantity of a drug that is not commercially available and to provide the drug to a health professional for the purpose of direct administration to patients.
· Specifies that the pharmacist's provision of the compounded drug must occur as an occasional exception to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.
CONTENT AND OPERATION
Continuing law defines drug "compounding" as the preparation, mixing, assembling, packaging, and labeling of one or more drugs by a licensed pharmacist. Compounding is included as one of the activities that constitutes the practice of pharmacy, but the circumstances under which a pharmacist may compound drugs were limited to the following under law revised by the act:
(1) Pursuant to a prescription issued by a licensed health professional authorized to prescribe drugs;[1]
(2) Pursuant to the modification of a prescription made in accordance with a consult agreement;[2]
(3) As an incident to chemical analysis, research, or teaching;
(4) In anticipation of prescription drug orders based on routine, regularly observed dispensing patterns.[3]
(R.C. 4729.01(C))
The act specifies an additional circumstance under which a pharmacist may compound drugs. Under this circumstance, pharmacists are given a limited authority to compound and provide drugs without patient-specific prescriptions.
Specifically, the act provides that compounding may occur 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:
(1) 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;
(2) A limited quantity of the drug is compounded and provided to the professional;
(3) The drug is compounded and provided to the professional as an occasional exception to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.
(R.C. 4729.01(B))
The act includes technical corrections in the definitions that are used in the statutes governing the practice of pharmacy.
HISTORY
|
ACTION |
DATE |
JOURNAL ENTRY |
|
|
|
|
|
Introduced |
01-25-05 |
p. 73 |
|
Reported,
S. Health, Human |
|
|
|
Passed Senate (30-1) |
02-22-05 |
pp. 193-194 |
|
Reported, H. Health |
04-21-05 |
pp. 697-698 |
|
Passed House (97-1) |
04-27-05 |
pp. 723-724 |
|
Senate
concurred in House |
|
|
05-SB18-126.doc/jc
* The Legislative Service Commission had not received formal notification of the effective date at the time this analysis was prepared. Additionally, the analysis may not reflect action taken by the Governor.
[1] "Licensed health professional authorized to prescribe drugs" means an individual authorized by law to prescribe drugs or dangerous drugs or drug therapy related devices in the course of the individual's professional practice, including the following professionals licensed under Ohio law: dentists; nurses who hold a certificate to prescribe; optometrists who hold a therapeutic pharmaceutical agents certificate; physicians authorized to practice medicine, osteopathic medicine, or podiatric medicine; and veterinarians (R.C. 4729.01(I)).
[2] A consult agreement is an agreement between a pharmacist and physician to manage an individual's drug therapy (R.C. 4729.01(D)).
[3] R.C. 4729.01(C).