State Board of Pharmacy; 77 South High Street, 17th Floor; Columbus, Ohio 43266-0320

Phone: 614/466-4143 <> Email: exec@bop.state.oh.us <> Fax: 614/752-4836

RULES EFFECTIVE IN 2000 SHOWING CHANGES

[Ohio Administrative Code]

I N D E X

Pharmacy Practice

4729-5-10   Prescription pick-up station.

4729-5-13   Prescription format.

4729-5-16   Labeling of drugs dispensed on prescription.

4729-5-17   Labeling by prescribers who personally furnish dangerous drugs to their patients.

4729-5-19   Serial numbering of prescriptions.

4729-5-24   Prescription copy.

4729-5-30   Manner of issuance of prescription.

4729-5-33   Criteria for re-licensure by reciprocity.

Dangerous Drugs

4729-9-14   Records of controlled substances.

4729-9-22   Records of dangerous drugs.

Controlled Substances

4729-11-01  Controlled substance schedule I.

4729-11-02  Controlled substance schedule II.

4729-11-03  Controlled substance schedule III.

4729-11-04  Controlled substance schedule IV.

4729-11-09  Sale of schedule V controlled substance products without a prescription.

Ephedrine

4729-12-02  Registration and licensure.

4729-12-03  Security, storage, and sale.

4729-12-04  Inventory.

4729-12-05  Records.

4729-12-08  Petitions for exception of ephedrine-containing products.

Retail Sellers of Oxygen

4729-22-04  Prescriber's order.

Emergency Medical Services

4729-33-01  Definitions.

4729-33-02  Licensure.

4729-33-03  Security and storage of dangerous drugs.

4729-33-04  Recordkeeping.

4729-33-05  Posting up.

F U L L   T E X T

ALL CAPS = New Language Strike Through = Remove Language

4729-5-10 Prescription pick-up station.  [OAC: 03/31/00]

(A)   No pharmacist shall accept prescriptions obtained from a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled UNLESS SUCH PLACE IS A PHARMACY AS DEFINED IN SECTION 4729.01 OF THE REVISED CODE, HAS RECEIVED BOARD APPROVAL TO FUNCTION IN SUCH A MANNER., AND ALL OF THE FOLLOWING APPLY:

(1)   THE SITE IS LICENSED WITH THE STATE BOARD OF PHARMACY AS A TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS;

(2)   THE RECEIPT, STORAGE, CONTROL, AND DISTRIBUTION OF PRESCRIPTIONS ARE IN THE FULL AND ACTUAL CHARGE OF A PHARMACIST LICENSED PURSUANT TO CHAPTER 4729. OF THE REVISED CODE;

(3)   AN APPROPRIATE RECORDKEEPING SYSTEM IS IN PLACE THAT WILL PROVIDE ACCOUNTABILITY FOR PROPER RECEIPT, DELIVERY, AND RETURN OF ALL PRESCRIPTIONS;

(4)   THERE IS A DOCUMENTED METHOD IN PLACE TO ENSURE COMPLIANCE WITH RULE 4729-5-22 OF THE ADMINISTRATIVE CODE.

(B)   No pharmacist shall dispense dangerous drugs to a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled or delivered unless SUCH PLACE IS A PHARMACY AS DEFINED IN SECTION 4729.01 OF THE REVISED CODE, HAS RECEIVED BOARD APPROVAL TO FUNCTION IN SUCH A MANNER, AND PARAGRAPHS (B)(1) THROUGH (B)(4) OF THIS RULE APPLY OR, IF NOT A PHARMACY, UNLESS all of the following apply:

(1)   The site is licensed with the state board of pharmacy as a terminal distributor of dangerous drugs.

(2)   The receipt, storage, control, and distribution of prescriptions or drugs are in the full and actual charge of a health care professional licensed pursuant to Chapter 4723., 4729., or 4731. of the Revised Code.

(3)   An appropriate recordkeeping system is in place that will provide accountability for proper receipt, and delivery, AND RETURN of all prescription medications.

(4)   There is a documented method in place to ensure compliance with rule 4729-5-22 of the Administrative Code.

(5)   The state board of pharmacy has approved the site for such activity due to clear and convincing evidence that delivery of prescription medication directly to the patient would result in:

(a)   Danger to public health or safety, or

(b)   Danger to the patient without increased involvement by a health care professional in the patient’s drug therapy.

4729-5-13 Prescription format.  [OAC: 03/31/00]

EXCEPT AS PROVIDED IN RULE 4729-5-14 OF THE ADMINISTRATIVE CODE:

(A)   No pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met:

(1)   The prescription is issued in compliance with rule 4729-5-30 of the Administrative Code.

(2)   If preprinted with multiple drug name and strength combinations:

(a)   There are no controlled substances among the choices;

(b)   There is only one prescription order selected per form.

(B)   No prescriber shall write and no pharmacist shall dispense controlled substances pursuant to a written outpatient prescription unless the following conditions are met:

(1)   The prescription has been issued in compliance with rule 4729-5-30 of the Administrative Code.

(2)   The prescription contains only one prescription order per prescription form, whether handwritten or preprinted.

(3)   The quantity has been written both numerically and alphabetically.

(4)   If preprinted, there is only one drug and strength combination printed on the form.

(C)   A prescription issued by a medical intern, resident, or fellow as defined in paragraph (B) of rule 4729-5-15 of the Administrative Code may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

(D)   A prescription issued by a staff prescriber of a hospital may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

4729-5-16 Labeling of drugs dispensed on prescription. [OAC: 03/31/00]

(A)   No drug may be dispensed on prescription unless a label is affixed to the container in which such drug is dispensed and such label includes:

(1)   The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license UNLESS IT IS FILLED PURSUANT TO A BOARD-APPROVED CENTRAL FILLING OPERATION, IN WHICH CASE THE LABEL SHALL BEAR THE NAME AND ADDRESS OF THE ORIGINATING PHARMACY AS IT APPEARS ON THE TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS LICENSE;

(2)   The name of the patient for whom the drug is prescribed; or, if the patient is an animal, the name of the owner and the species IDENTIFICATION of the animal;

(3)   The name of the prescriber;

(4)   Directions for use of the drug;

(5)   The date of dispensing;

(6)   Any cautions which may be required by federal or state law;

(7)   The serial number of the prescription;

(8)   The proprietary name, if any, or the generic name and the name of the distributor of the drug dispensed; and the strength, if more than one strength of the drug is marketed. The dispensing pharmacist may omit the name and strength of the drug only if the prescriber specifically requests omission in writing in the case of a written prescription, or verbally in the case of an orally transmitted prescription;

(9)   The quantity of drug dispensed;

(10)  IF FILLED AS PART OF A BOARD-APPROVED CENTRAL FILLING OPERATION, AN IDENTIFICATION OF THE PHARMACY PROVIDING THE DRUGS FOR THE DISPENSING OPERATION.

(B)   The term "affix" means the prescription label must be attached or fastened to the container.

(C)   At least the prescription number and the name of the patient must be placed on all prescription containers too small to bear a complete prescription label and dispensed in a container bearing a complete prescription label. The label bearing only the prescription number and the name of the patient does not need to be applied to any product whose function would be impaired by such a label. In all cases, a complete prescription label meeting the requirements of paragraph (A) of this rule must be applied to the container in which such product is dispensed.

(D)   This rule does not apply to drugs which are dispensed for use by inpatients of an institutional facility whereby the drug is not in the possession of the ultimate user prior to administration. Such drugs shall be labeled in accordance with rule 4729-17-10 of the Administrative Code.

4729-5-17   Labeling by prescribers who personally furnish dangerous drugs to their patients.  [OAC: 03/31/00]

(A)   Whenever a prescriber personally furnishes a dangerous drug, other than a sample drug pursuant to section 3719.81 of the Revised Code, the prescriber shall affix to the container a label showing:

(1)   The name and address of the prescriber.

(2)   The name of the patient for whom the drug is intended. If the patient is an animal, the name of the owner and the species IDENTIFICATION of the animal.

(3)   Name and strength of the dangerous drug.

(4)   Directions for use.

(5)   Date furnished.

(B)   Whenever a prescriber personally furnishes a dangerous drug, labeled as a sample pursuant to section 3719.81 of the Revised Code and where the directions for use are different from the directions on or in the sample container, the prescriber shall also provide, in written format, the following:

(1)   Name of the prescriber.

(2)   Name of the patient. If the patient is an animal, the name of the owner and the species IDENTIFICATION of the animal.

(3)   Directions for use.

4729-5-19 Serial numbering of prescriptions.  [OAC: 03/31/00]

All outpatient prescriptions must be serially numbered when entered into the computer system or when dispensed under a manual system.

(A)   This number must appear on the original prescription. If an alternate recordkeeping system is being used pursuant to rules 4729-5-27 and 4729-5-28 of the Administrative Code, the serial number must also appear on the records in this alternate system.

(B)   There must be a complete accounting of all numbers used in the serial numbering system.

(C)   All prescriptions which are not refillable, either because of the dispensing of all refills or the length of time since issuance, shall be assigned a new serial number upon authorization by the prescriber to continue the medication, except:

(1)   The prescriber may authorize additional refills of a schedule III or IV controlled substance through an oral refill authorization transmitted to a pharmacist, provided the additional refills do not exceed five refills of the original prescription nor does any refill occur beyond six months from the date of issuance of the original prescription; or

(2)   The prescriber may authorize additional refills of a schedule V controlled substance or a non-controlled drug through an oral refill authorization transmitted to a pharmacist provided that no refill may occur beyond one year from the date of issuance of the original prescription.

(3)   All additional refills authorized by the prescriber shall be marked on the original prescription listing authorizing agent, date, number of refills authorized, and pharmacist receiving the authorization. If an alternative recordkeeping system is used, this information must also be maintained in that system.

(D)   IN THE CASE OF A BOARD-APPROVED CENTRAL FILLING OPERATION IN WHICH THE PHARMACIES ARE ACCESSING THE SAME REAL-TIME, ON-LINE DATABASE, THE SERIAL NUMBER USED MAY BE THE ORIGINAL SERIAL NUMBER ISSUED AT THE ORIGINATING PHARMACY IF ALL OF THE FOLLOWING REQUIREMENTS ARE MET:

(1)   THE COMPUTER SYSTEM MAINTAINS THE APPROPRIATE RECORDS FOR THE PRESCRIPTION SO THAT IT IS POSSIBLE TO DETERMINE THE IDENTITY OF EVERY PERSON INVOLVED IN THE DISPENSING OF THE PRESCRIPTION WHO PERFORMS AN ACT THAT WOULD CONSTITUTE THE PRACTICE OF PHARMACY.

(2)   THE COMPUTER SYSTEM ASSIGNS A UNIQUE INTERNAL CODE TO THE PRESCRIPTION SO THAT IT IS POSSIBLE TO DETERMINE THE LOCATION OF THE PERSONNEL INVOLVED IN THE DISPENSING AS WELL AS THE LOCATION OF THE DRUG STOCK USED IN THE DISPENSING FUNCTION.

4729-5-24 Prescription copy.  [OAC: 03/31/00]

(A)   A pharmacist may transfer a copy of a prescription; a pharmacist may refill a copy of a prescription; such actions must be in accordance with the following:

(1)   Copies of prescriptions shall be transferred only between pharmacists; copies of prescriptions for controlled substances pursuant to sections 3719.41, 3719.43, and 3719.44 of the Revised Code shall be communicated directly between two pharmacists and shall be transferred only one time. However, pharmacies electronically sharing a real-time, on-line database may transfer a controlled substance prescription up to the maximum number of refills permitted by law and the prescriber's authorization pursuant to paragraph (A)(4) of this rule.

(2)   The copy transferred shall be an exact duplicate of the original prescription except that it shall also include:

(a)   Serial prescription number assigned to the prescription;

(b)   Name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy transferring the copy;

(c)   Date of issuance of the prescription;

(d)   Date of original dispensing of the prescription;

(e)   Original number of refills;

(f)   Date of last refill;

(g)   Number of valid refills remaining; and

(h)   The name of the transferring pharmacist.

(3)   Copies transferred for non-refillable prescriptions shall be marked on the face of the prescription or orally noted by the transferring pharmacist "For Information Purposes Only" and are not valid prescriptions for the dispensing of drugs.

(4)   The pharmacist transferring a copy of a prescription must:

(a)   Cancel the original prescription by writing the word "void" on the face of the prescription in such a way as to avoid destroying any of the original information contained on the prescription;

(b)   Record on the reverse side of the original written prescription:

(i)   Date of transfer;

(ii)  His/her signature; and

(iii) When transferring an oral prescription, the name and address (and "D.E.A." number for controlled substance prescriptions) OF, and name of the pharmacist at, the receiving pharmacy.

(c)   Except, if an automated data processing system is being used as an alternate system of recordkeeping for prescriptions pursuant to rules 4729-5-27 and 4729-5-28 of the Administrative Code, copies of prescriptions may be transferred by a pharmacist if the prescription record in the system is invalidated to prevent further dispensing at the original site. The prescription record in the system must contain the date of transfer, name of pharmacist making transfer, and the name and address of the pharmacy receiving the copy. Also, original written prescriptions for controlled substances must be canceled as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.

(5)   The pharmacist receiving a copy of a prescription must:

(a)   Exercise reasonable diligence to determine validity of the copy;

(b)   Reduce an oral prescription to writing by recording all of the information transferred (must include all information required in paragraph (A)(2) of this rule) and write the word "transfer" on the face of the prescription;

(c)   Record date of transfer on the face of the prescription.

(B)   A prescription copy may be transferred between two pharmacies if the two pharmacies are accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner. The computerized systems must satisfy all information requirements of paragraphs (A)(2) and (A)(4)(c) of this rule. This shall include invalidation of the prescription record in the system to prevent further dispensing at the original site and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule. A system must be in place that will allow only authorized access to these computerized prescription records by a pharmacist and indicate on the prescription record when and by whom such access was made.

(C)   A prescription copy may be transferred between two pharmacists by the use of a facsimile machine. This facsimile may be considered to be a copy of a prescription if all information requirements of paragraph (A) of this rule, including invalidation of the original prescription or computer records, are met. A system must be in place that will show on the facsimile positive identification of the transferring and receiving pharmacists which must become a part of the prescription record. Facsimile copies must be recorded in writing pursuant to section 4729.37 of the Revised Code, or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

(D)   Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient. Original copies of prescriptions shall be maintained by pharmacies for the purpose of documenting the dispensing of drugs to a particular patient.

(1)   In the event that the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharmacist shall, upon the request of the patient, transfer the prescription information to the pharmacy designated by the patient.

(2)   No pharmacy shall refuse to transfer information about a previously dispensed prescription to another pharmacy when requested by the patient. Prescription information shall be transferred in accordance with this rule as soon as possible in order to assure that the patient’s drug therapy is not interrupted.

(E)   Prescriptions entered into a computer system but not dispensed may be transferred to another pharmacy if all of the following conditions are met:

(1)   The complete prescription information has been entered into the computer system;

(2)   The information is displayed on the patient’s profile;

(3)   There is positive identification, either in the computer system or on the hard-copy prescription, of the pharmacist who is responsible for entering the prescription information into the system;

(4)   The original prescription is filed in accordance with rule 4729-5-09 of the Administrative Code;

(5)   All requirements of this rule are met for the transfer of the prescription.

(F)   TRANSFER OF PRESCRIPTION INFORMATION BETWEEN TWO PHARMACIES WHICH ARE ACCESSING THE SAME REAL-TIME, ON-LINE DATABASE PURSUANT TO THE OPERATION OF A BOARD-APPROVED CENTRAL FILLING OPERATION SHALL NOT BE CONSIDERED A PRESCRIPTION COPY AND, THEREFORE, IS NOT SUBJECT TO THE REQUIREMENTS OF THIS RULE.

4729-5-30 Manner of issuance of prescription.  [OAC: 03/31/00]

(A)   A prescription, to be effective, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her professional practice. The responsibility for the proper prescribing is upon the prescriber, but a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law.

(B)   All prescriptions shall be dated as of and signed on the day when issued, and shall bear the full name and address of the patient.

(C)   All written prescriptions issued by a prescriber shall bear the full name and address of the prescriber and shall be manually signed by the prescriber in the same manner as he/she would sign a check or legal document.

(D)   An original signed prescription (for other than a schedule II controlled substance except as noted in paragraph (N) of this rule and rules 4729-17-09 and 4729-19-02 of the Administrative Code) may be transmitted as an "other means of communication" to a pharmacist PHARMACY by the use of a facsimile machine only by a prescriber or the prescriber's agent. Such a facsimile shall only be valid as a prescription if a system is in place that will allow the pharmacist to maintain the facsimile as a part of the prescription record including the positive identification of the prescriber and his/her agent as well as positive identification of the origin of the facsimile. The pharmacist must record the prescription in writing pursuant to section 4729.37 of the Revised Code or store the facsimile copy in such a manner that will allow retention of the prescription record for three years from the date of the last transaction. The original signed prescription from which the facsimile is produced shall not be issued to the patient. The original signed prescription must remain with the patient’s records at the prescriber’s office or the institutional facility where it was issued. IF A BOARD-APPROVED ELECTRONIC PRESCRIPTION TRANSMISSION SYSTEM IS USED TO FAX THE PRESCRIPTION, THE COMPUTER DATA MUST BE RETAINED FOR A PERIOD OF THREE YEARS AT THE PRESCRIBER'S OFFICE. A facsimile of a prescription received by a pharmacist PHARMACY in any manner other than transmission directly from the prescriber or the prescriber’s agent shall not be considered a valid prescription, except as a copy of a prescription pursuant to rule 4729-5-24 of the Administrative Code.

(E)   All prescriptions shall specify the number of times or the period of time for which the prescription may be refilled. A prescription marked "Refill P.R.N." or some similar designation is not considered a valid refill authorization.

(F)   Prescriptions for dangerous drugs may not be dispensed for the first time beyond six months from the date of issuance by a prescriber.

(G)   Prescriptions for dangerous drugs and controlled substances in schedule V may not be authorized for refill beyond one year from the date of issuance. Prescriptions for controlled substances in schedules III and IV shall be authorized for refill only as permitted by section 3719.05 of the Revised Code. Prescriptions for controlled substances in schedule II may not be refilled.

(H)   A prescription may be refilled only as expressly authorized by the prescriber, either in writing or orally. If no such authorization is given, the prescription may not be refilled except in accordance with section 4729.281 of the Revised Code.

(I)   The drug(s) in a compounded prescription or drug product shall be identified by the product trade name or generic name.

(J)   No prescription shall be coded in such a manner that it cannot be dispensed by any pharmacy of the patient's choice. A "coded prescription" is one which bears letters, numbers, words or symbols, or any other device used in lieu of the name, quantity, strength and directions for its use, other than those normal letters, numbers, words, symbols, or other media recognized by the profession of pharmacy as a means of conveying information by prescription. No symbol, word, or any other device shall be used in lieu of the name of said preparation.

(K)   The agent of a prescriber who transfers a facsimile of an original prescription or transmits an oral prescription or authorization of a refill for a dangerous drug must identify themselves by full name and the pharmacist shall make a record of the prescriber's agent on the original prescription and, if used, on the alternate system of recordkeeping. A pharmacist who modifies a patient's drug therapy, pursuant to a consult agreement, must personally transmit the facsimile or oral order to another pharmacist, if the drug is not dispensed by the pharmacist who modified the drug order.

(L)   When forms are used that create multiple copies of a prescription issued to a patient by a prescriber, the original prescription which also bears the actual signature of the prescriber must be issued to the patient for dispensing by a pharmacist.

(M)   A pharmacist may accept, without further verification of the prescriber’s identity required, a prescription that has been transmitted by means of a board approved BOARD-APPROVED automated paperless system. The system shall require positive identification of the prescriber as defined in rule 4729-5-01 of the Administrative Code as well as the full name of any authorized agent of the prescriber who transmits the prescription.

(N)   A schedule II controlled substance prescription for a narcotic substance issued for a patient enrolled in a hospice may be transmitted by the prescriber or the prescriber's agent to the pharmacy by facsimile. The original prescription must indicate that the patient is a hospice patient. The facsimile transmission must meet all of the requirements in paragraph (D) of this rule for such a prescription.

(O)   When a pharmacist, acting as an agent of the physician, modifies a patient’s drug therapy pursuant to a consult agreement, the pharmacist must comply with this rule in the same manner as a prescriber and include the name of the physician who originally prescribed the drug and sign the pharmacist's full name.

(P)   A PRESCRIPTION ORALLY TRANSMITTED BY TELEPHONE TO A PHARMACY BY A PRESCRIBER OR THE PRESCRIBER'S AGENT MAY BE PLACED ON A RECORDING DEVICE AT THE PHARMACY IF THE PHARMACIST IS UNAVAILABLE. THE PRESCRIBER OR PRESCRIBER'S AGENT MUST PROVIDE HIS/HER COMPLETE NAME. THE PHARMACIST MUST REMOVE THE PRESCRIPTION FROM THE RECORDER AND REDUCE IT TO WRITING. THE PHARMACIST IS RESPONSIBLE FOR ASSURING THE VALIDITY OF THE PRESCRIPTION REMOVED FROM THE RECORDER.

4729-5-33 Criteria for re-licensure by reciprocity.  [OAC: 03/31/00]

A person who has been registered as a pharmacist pursuant to section 4729.07 or 4729.09 of the Revised Code, and whose identification card has lapsed, may obtain an identification card to practice pharmacy in Ohio pursuant to section 4729.09 of the Revised Code provided he/she:

(A)   Submits evidence of having obtained four and one-half "C.E.U.s" of approved continuing pharmacy education pursuant to Chapter 4729-7 MET THE REQUIREMENTS OF RULE 4729-7-02 of the Administrative Code during the three-year period immediately preceding the date of application; or

(B)   Is reciprocating from a state where continuing pharmacy education is mandatory and submits evidence of having met the continuing pharmacy education requirements of that state.

4729-9-14 Records of controlled substances.  [OAC: 03/31/00]

(A)   Each prescriber or terminal distributor of dangerous drugs shall keep a record of all controlled substances received, administered, dispensed, sold, or used.

(1)   Records of receipt shall contain a description of all controlled substances received, the kind and quantity of controlled substances received, the name and address of the persons from whom received, and the date of receipt.

(2)   Records of administering, dispensing, or using controlled substances shall contain a description of the kind and quantity of the controlled substance administered, dispensed, or used, the date, the name and address of the person to whom, or for whose use, or the owner and species IDENTIFICATION of the animal for which, the controlled substance was administered, dispensed, or used.

(3)   Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the name and address requirements of paragraph (A)(2) of this rule.

(B)   Each prescriber or terminal distributor of dangerous drugs shall maintain an inventory of all controlled substances as follows:

(1)   Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken.

(a)   The name of the substance.

(b)   The total quantity of the substance.

(i)   Each finished form (e.g., ten-milligram tablet or ten-milligram concentration per fluid ounce or milliliter).

(ii)  The number of units or volume of each finished form in each commercial container (e.g., one-hundred-tablet bottle or ten-milliliter vial).

(iii) The number of commercial containers of each such finished form (e.g., three one-hundred-tablet bottles or ten one-milliliter vials).

(c)   If the substance is listed in schedule I or II, the prescriber or terminal distributor of dangerous drugs shall make an exact count or measure of the contents.

(d)   If the substance is listed in schedule III, IV, or V, the prescriber or terminal distributor of dangerous drugs shall make an estimated count or measure of the contents, unless the container holds more than one thousand tablets or capsules in which an exact count of the contents must be made.

(2)   A separate inventory shall be made for each place or establishment where controlled substances are in the possession or under the control of the prescriber or terminal distributor. Each inventory for each place or establishment shall be kept at the place or establishment.

(3)   An inventory of all stocks of controlled substances on hand on the date the prescriber or terminal distributor first engages in the administering, dispensing, or use of controlled substances. In the event the prescriber or terminal distributor of dangerous drugs commences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

(4)   Each prescriber or terminal distributor of dangerous drugs shall take a new inventory of all stocks of controlled substances on hand every two years following the date on which the initial inventory is taken.

(5)   When a substance is added to the schedule of controlled substances by the federal drug enforcement administration or the state board of pharmacy, each prescriber or terminal distributor of dangerous drugs shall take an inventory of all stock of such substance on hand at that time.

(6)   All records of receipt, distribution, administering, dispensing, inventory, or using controlled substances shall be kept for a period of three years at the place where the controlled substances are located. Any prescriber or terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send notification to the state board of pharmacy; if not contested by the board within sixty days, it will stand as approved.

4729-9-22 Records of dangerous drugs.  [OAC: 03/31/00]

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all dangerous drugs received, administered, dispensed, distributed, sold, or used.

(A)   Records of receipt shall contain a description of all dangerous drugs received, the kind and quantity of dangerous drugs received, the name and address of the persons from whom received, and the date of receipt.

(B)   Records of administering, dispensing, or using dangerous drugs shall contain a description of the kind and quantity of the dangerous drugs administered, dispensed, sold, or used, the date, the name and address of the person to whom, or for whose use, or the owner and species IDENTIFICATION of the animal for which, the dangerous drug was administered, dispensed, or used.

(C)   Records of dangerous drugs, other than controlled substances, administered, dispensed, or used which become a permanent part of the patient's medical record shall be deemed to meet the requirements of paragraph (B) of this rule.

(D)   All records of receipt, distribution, administering, dispensing, selling, or using dangerous drugs shall be kept for a period of three years at the place where the dangerous drugs are located. Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send notification to the state board of pharmacy by certified mail, return receipt requested; if not contested by the board within sixty days, it will stand as approved. A copy of the request with the return receipt shall be maintained with the other records of dangerous drugs. Any such alternate location shall be secured and accessible only to representatives of the terminal distributor.

4729-11-01 Controlled substance schedule I.

4729-11-02 Controlled substance schedule II.

4729-11-03 Controlled substance schedule III.

4729-11-04 Controlled substance schedule IV.

Rescinded effective 03/31/00 to remove duplication of the Revised Code. The rescission of these rules will NOT affect "Ohio's Schedules of Controlled Substances" list as it is currently in effect.

4729-11-09 Sale of schedule V controlled substance products without a prescription.  [OAC: 03/31/00]

A schedule V controlled substance product which is not a prescription drug as determined under the “Federal Food, Drug and Cosmetic Act” may be sold at retail by a pharmacist without a prescription to a purchaser at retail, provided that:

(A)   the sale is made only by a pharmacist OR A PHARMACY INTERN UNDER THE DIRECT SUPERVISION OF A PHARMACIST and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities in this section, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist).

(B)   the purchaser is at least eighteen years of age.

(C)   the pharmacist requires every purchaser of a controlled substance under this rule not known to him to furnish suitable identification (including proof of age where appropriate).

(D)   a bound record book is maintained which contains the true name and complete address of the purchaser, the legible signature of the purchaser, the name and quantity of controlled substances sold, the date of each sale, and the name and legible initials of the pharmacist who sold the controlled substance at retail. This book shall be maintained for a period of three years from the date of the last transaction and must be made available for inspection and copying by persons authorized to enforce the federal and state drug laws.

(E)   the schedule V controlled substance product is sold at retail.

(F)   not more than two hundred forty milliliters (eight ounces) nor more than forty-eight solid dosage units of any schedule V controlled substance product containing opium, nor more than one hundred twenty milliliters (four ounces) nor more than twenty-four solid dosage units of any other narcotic controlled substance may be sold at retail to the same purchaser in any consecutive forty-eight-hour period.

(G)   not more than one hundred solid dosage units of any schedule V controlled substance stimulant product may be sold to any one person in any consecutive thirty-day period.

(H)   the schedule V controlled substance is sold at retail for a legitimate medical need and the purchaser furnishes information to the pharmacist which establishes the legitimate medical need for the controlled substance.

4729-12-02 Registration and licensure.  [OAC: 03/31/00]

(a)   Any person who manufactures, sells at wholesale or retail, dispenses, imports or exports products containing ephedrine, its salts or isomers, or who proposes to engage in such activities, shall submit an application for registration as a wholesaler of dangerous drugs and controlled substances or for licensure as a category III terminal distributor of dangerous drugs to conduct such activities in accordance with Chapters 3719. and 4729. of the Revised Code.

(B)   THIS RULE DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

4729-12-03 Security, storage, and sale.  [OAC: 03/31/00]

(a)   Schedule V products containing ephedrine may be sold at wholesale or retail, and must be maintained in accordance with Chapters 3719. and 4729. of the Revised Code and Chapters 4729-9 and 4729-11 of the Administrative Code.

(B)   THIS RULE DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

4729-12-04 Inventory.  [OAC: 03/31/00]

(a)   Every registrant or licensee required to keep records who possesses any quantity of ephedrine or schedule V drug products containing ephedrine shall take an inventory pursuant to rules 4729-9-14 and 4729-9-16 of the Administrative Code.

(B)   THIS RULE DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

4729-12-05 Records.  [OAC: 03/31/00]

(a)   All practitioners, registrants, and licensees required to keep records pursuant to Chapter 3719. of the Revised Code and Chapters 4729-9 and 4729-11 of the Administrative Code shall maintain such records for ephedrine and schedule V drug products containing ephedrine.

(B)   THIS RULE DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

4729-12-08 Petitions for exception of ephedrine-containing products.  [OAC: 03/31/00]

(a)   A petition requesting that a drug product containing ephedrine be excepted by the board of pharmacy from being legally classified as a schedule V controlled substance stimulant may be submitted by any person engaged in the legitimate manufacture or wholesale sale of such products in the United States. The petition shall include the following information:

(A) (1)   full name, address, and telephone number of the manufacturer.

(1) (a)   If incorporated, the petition must include copies of the incorporation papers and the names, dates of birth, addresses, and social security numbers of the officers of the corporation and all stockholders holding more than ten per cent of the stock.

(2) (b)   If a proprietorship, the petition must include the name, address, date of birth, and social security number of the owner(s).

(3) (c)   If a partnership, the petition must include the names, addresses, dates of birth, and social security numbers of the partners.

(B) (2)   a description of the package sizes and the manner of packaging the drug product.

(C) (3)   A limited number of samples of each dosage form marketed in the final marketed packages.

(D) (4)   the manner of distribution, advertising, and promotion of the product, including but not limited to:

(1) (a)   the full name and address of all accounts located in Ohio to which the products have been or will be distributed at wholesale based on other products marketed by the petitioner.

(2) (b)   Copies of all advertisements used to promote the product within the last twelve months shall be included with the petition. A list of the publications in which the advertisements appeared or will appear if not presently marketed. if the product has not yet been marketed, copies of other products marketed by the petitioner shall be submitted with the petition.

(E) (5)   a listing of all ingredients in the product, indicating the quantity of each ingredient, whether or not it has any therapeutic value, and its purpose for being included in the product. Documentation of the therapeutic value of all active ingredients in the product shall be included with the petition.

(F) (6)   A list of all names the product is marketed or will be marketed under in the United States or any other country.

(G) (7)   any information regarding the product’s abuse or potential for abuse in the United States or other countries where the product is marketed or will be marketed under any of the names listed in paragraph (F) (A)(6) of this rule.

(B)   THIS RULE DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

4729-22-04 Prescriber's order.  [OAC: 03/31/00]

Before making an initial sale of medical oxygen to a patient, the retail seller must have an order issued by a person authorized to prescribe oxygen in the course of the prescriber’s professional practice. the order must include the full name and address of the patient, the name and address of the prescriber, and documentation of need. THIS ORDER MUST BE RENEWED AT LEAST ANNUALLY.

4729-33-01 definitions.  [OAC: 08/15/00]

As used in THIS chapter:

(a)   “dangerous drug” has the same meaning as in section 4729.01 of the revised code.

(B)   “controlled substance” has the same meaning as in section 4729.01 of the revised code.

(C)   “terminal distributor of dangerous drugs” has the same meaning as in section 4729.01 of the revised code.

(D)   “Emergency medical service (ems) organization” has the same meaning as in section 4765.01 of the revised code.

(E)   “mutual aid” means a formal agreement between two or more ems organizations to assist in emergency medical coverage in the other’s usual area of coverage including having access to dangerous drugs during the emergency situation.

(F)   “posting up” means locating an ems unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy.

(G)   “posting up at a special event” means locating an ems unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy pursuant to a formal agreement with the sponsors of the special event.

(H)   “special event” means an event requiring ems coverage for more than TWENTY-FOUR HOURS including, but not limited to, the following:

(1)   A county fair.

(2)   A weekend festival.

(I)   “scope of practice” shall be as defined in SECTION 4765.35 of the revised code for a first responder, SECTION 4765.37 of the revised code for an emergency medical technician-basic, SECTION 4765.38 of the revised code for an emergency medical technician-intermediate, and SECTION 4765.39 of the revised code for an emergency medical technician-paramedic.

(J)   “CERTIFICATION” MEANS THE LEVEL TO WHICH AN INDIVIDUAL IS TRAINED AND LICENSED AS DEFINED IN SECTION 4765.01 OF THE REVISED CODE AND RULE 4765-1-01 of the administrative code.

(K)   “medical director” has the same meaning as in RULE 4765-10-06 of the administrative code.

(L)   “responsible person” has the same meaning as in RULE 4729-13-01 of the administrative code.

(M)   “standing order” and “protocol” have the same meanings as in RULE 4729-5-01 of the administrative code.

(N)   “satellite” means an address licensed by the board as a terminal distributor of dangerous drugs that is separate from the licensed headquarters address of the ems organization.

(O)   “tamper-evident” means the package is sealed in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(P)   “readily retrievable” means all records which are required to be maintained must be provided upon request to the inspector or agent of the board of pharmacy within THREE working days.

4729-33-02 licensure.  [OAC: 08/15/00]

(a)   Any EMERGENCY MEDICAL SERVICE (ems) organization that desires to stock dangerous drugs shall apply for and maintain a license as a terminal distributor of dangerous drugs. The one location that serves as the main station will be deemed the headquarters location. Any other locations associated with this headquarters where dangerous drugs will be stored will be licensed as “satellites”. Only the headquarters location will be charged a LICENSE fee or renewal LICENSE fee.

(B)   Each location, headquarters and satellites, must be licensed as a limited terminal distributor of dangerous drugs and must maintain a current TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS license and drug addendum.

(C)   An application for licensure MUST include all of the following:

(1)   A completed application;

(2)   A compilation of all protocols involving dangerous drugs that have been signed by the medical director and notarized;

(3)   A list of drugs referenced in the protocols to be stocked by the ems organization, signed by the medical director and notarized;

(4)   A list of personnel employed by the ems organization who may access and administer dangerous drugs, which includes the name of the individual, level of certification, their certification number, and expiration date;

(5)   A list of any and all formal mutual aid agreements with other ems organizations;

(6)   The fee for the appropriate category of licensure.

(D)   Each location, headquarterS and satellite, may only possess those dangerous drugs that are listed on the drug addendum and only at locations licensed by the board of pharmacy.

(1)   A medical director may add dangerous drugs to the drug list by submitting revised, signed and notarized protocols and list of medications, and the addendum update fee.

(2)   A medical director may delete dangerous drugs from the drug list by submitting a letter listing the drugs to be deleted.

(E)   A new application and fee is required prior to any change of location, addition of a satellite location, change of category, name change, or change of ownership. These changes may be made during the annual renewal period with no additional fee other than the renewal fee.

(F)   The responsible person shall provide supervision and control of all locations where dangerous drugs are stored. The responsible person must be a physician licensed pursuant to chapter 4731. Of the revised code or a pharmacist licensed pursuant to CHAPTER 4729. Of the revised code.

(1)   To change the responsible person, the new responsible person must complete and return a notification of change of responsible person form within THIRTY days.

(2)   To change the medical director, the new medical director must submit a signed and notarized letter stating that he/she is accepting responsibility for the ems organization.

(a)   If the new medical director approves of the current protocol and drug list, a signed and notarized letter mUST be submitted stating the current protocols and drug list on file have been reviewed and are approved by the medical director for use by this ems organization, OR

(b)   If the new medical director desires to change the protocols or drug list, the medical director must submit the revised, signed, and notarized protocols and drug list, AND THE ADDENDUM UPDATE FEE.

(G)   Any changes in protocols that involve dangerous drugs must be submitted to the STATE board of pharmacy prior to the implementation of the protocols involved. The STATE board of pharmacy may discuss such protocols with the STATE EMERGENCY MEDICAL SERVICES BOARD, STATE medical board, or other governmental agencies as needed to assure their validity.

(H)   any change of personnel requires a letter from the organization within THIRTY days of the change listing the type of change (addition, update, or deletion), names of the personnel involved, level of certification, their certification number, and expiration date.

4729-33-03 security and storage of dangerous drugs.  [OAC: 08/15/00]

(a)   Overall supervision and control of dangerous drugs is the responsibility of the responsible person. The responsible person may delegate the day-to-day tasks to the EMERGENCY MEDICAL SERVICE (ems) organization personnel who hold appropriate certification to access the dangerous drugs for which they are responsible.

(B)   All dangerous drugs must be secured in a tamper-evident setting with access limited to ems personnel based on their certification status except for sealed, tamper-evident solutions labeled for irrigation use. All registrants shall provide effective and approved controls and procedures to DETER AND DETECT theft and diversion of dangerous drugs.

(C)   Only paramedics, registered nurses, physicians, and pharmacists who are associated with that ems organization may have access to any controlled substances maintained by the ems organization. OTHER PERSONS EMPLOYED BY THE EMS ORGANIZATION MAY HAVE ACCESS TO CONTROLLED SUBSTANCES ONLY UNDER THE DIRECT AND IMMEDIATE SUPERVISION OF A PARAMEDIC, REGISTERED NURSE, OR PHYSICIAN IN EMERGENCY SITUATIONS.

(D)   Administration of dangerous drugs by an ems employee is limited to the scope of practice, as determined by the STATE EMERGENCY MEDICAL SERVICES board, for the individual’s certification level and the protocols as established by the medical director or when the individual is acting within their certification level pursuant to direct prescriber’s orders received over an active communication link.

(E)   All dangerous drugs will be maintained in a clean and temperature-controlled environment.

(F)   Any dangerous drug that reaches its expiration date is considered adulterated and must be separated from the active stock to prevent possible administration to patients.

(G)   Any non-controlled dangerous drug that is outdated may be returned to the supplier where the drug was obtained or may be disposed of in the proper manner.

(H)   Any controlled substance that is outdated may be returned to the supplier where the drug was obtained.

(I)   Destruction of outdated controlled substances may only be done by a STATE board OF PHARMACY agent or by prior written permission from the STATE board of pharmacy office.

(J)   Destruction of partially used controlled substances can be accomplished, with the appropriate documentation, by two licensed health care personnel, one of which must have at least a paramedic level of training.

(K)   Any loss OR theft of dangerous drugs must be reported upon discovery, by telephone, to the STATE board of pharmacy, local law enforcement and, if controlled substances are involved, to the DRUG ENFORCEMENT ADMINISTRATION. A report must be filed with the STATE board of pharmacy of any loss or theft of the vehicle or storage cabinets CONTAINING DANGEROUS DRUGS used by the ems organization.

(L)   Any dangerous drug showing evidence of damage or tampering shall be removed from stock and replaced immediately.

4729-33-04 recordkeeping.  [OAC: 08/15/00]

(a)   All EMERGENCY MEDICAL SERVICE (ems) organizations are required to keep complete and accurate records for at least THREE years of receipt, use, administration, destruction, and waste of dangerous drugs. These records must be readily available for inspection by STATE board of pharmacy agents or inspectors as per SECTION 3719.27 of the revised code and RULE 4729-5-29 of the administrative code.

(B)   Records from satellites may be stored at the headquarters if prior notice is sent to the board office. A letter requesting storage of records at the headquarters must be sent to the STATE board OF PHARMACY office by verifiable delivery. The board will notify the organization of the board’s approval or denial of the request within SIXTY days.

(C)   Records of oxygen transfilling shall include the manufacturer’s lot number of the oxygen used for transfilling the portable oxygen tanks.

(D)   If there is a recall of oxygen by the manufacturer, all portable oxygen tanks that may have any of that lot number shall be dealt with according to the manufacturer’s recommendations; but, in all such cases, such portable oxygen tanks must be purged and then refilled.

(E)   A readily retrievable record of controlled substances shall be kept containing documentation of administration, use, or waste of the controlled substances. Such records shall contain at least the following information:

(1)   The name, strength, and quantity of the controlled substance administered, used, or wasted;

(2)   The date of administration, use, or waste;

(3)   The name or other means of identifying the patient, such as medical record number or run number;

(4)   The signature and identification number of the individual administering the controlled substance;

(5)   IN THE CASE OF WASTE, THE SIGNATURES AND IDENTIFICATION NUMBERS OF BOTH INDIVIDUALS INVOLVED IN WASTING THE CONTROLLED SUBSTANCE.

4729-33-05 Posting up.  [OAC: 08/15/00]

(A)   Except when “posting up at a special event”, “posting up” must be a temporary, short-term location of the vehicle for less than TWENTY-FOUR hours where the ems unit is under constant supervision of the ems personnel on duty, including but not limited to:

(1)   Local school sports event;

(2)   Coverage of a station pursuant to a mutual aid agreement.

(B)   “posting up at a special event” requires prior written notification to, and approval FROM, the STATE board of pharmacy office. This notification must include the name and location of the event, dates of the event, and name and telephone number of the contact person of the ems unit.

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