Chapter 4729-10
Out Of State Pharmacies

(A) "Nonresident pharmacy" means any pharmacy, located outside of Ohio that ships, mails, or delivers, in any manner, drugs at retail into Ohio;

4729-10-02 Licensure

Must be registered in Ohio as a TDDD

Chapter 4729-11 Controlled substance schedules

• By regulation or legislation

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

• The sale is made only by a pharmacist or intern and not by a nonpharmacist employee even if under the supervision of a pharmacist

• Eighteen years of age.

• Suitable identification

• A bound record book is maintained

• Limits

Chapter 4729-12 Ephedrine.

Chapter 4729-17 Institutional Facilities

4729-17-01 Definitions;

• (A) "Institutional facility"

• (B) "Inpatient”

• (C) "Inpatient prescription"

• (D) "Dispensing of a drug pursuant to an inpatient prescription”

• (E) "Contingency drugs”

• (F) "Emergency drugs"

4729-17-02 Pharmacist in Charge

• (A) Responsible for:

• All pharmaceutical activities

• Services provided

• Security and control of all drugs in facility - not just pharmacy

• Maintenance of records

• Policies and procedures

• (B) Follow correct procedures when change in pharmacist in charge:

• Notice to board - certified mail return receipt

• Complete inventory of all controlled substances

4729-17-03 Security and control of drugs in institutional facility

(A) Absence of pharmacist -

Contingency Drug supplies

Locked cabinet or similar enclosure Located OUTSIDE of pharmacy

(A)(2)Pharmacist in charge to determine

-which drugs

-who may access

-drugs properly labeled

-security and inspections

(A)(3)When drug not available from contingency supply & needed for emergency then others may enter pharmacy

• -R.Ph. In charge to implement policies

• -Identify persons who can access pharmacy

• -2 employees

• -Written record

(B)Floor Supply Meds

• -Limited Quantity

• -Proper storage & labeling

• -Secure area or with tamper evident seal

• -Notify Rx when drugs accessed

• -Inspect regularly

• -Adequate recordkeeping

4729-17-04 Records Institutional Facility

• (A) Records of drugs purchased

• (B) All drug orders and dispensing records

• (C) Record of all drugs compounded and repackaged. Must include items listed in paragraph 1 - 7

· (D) Records of distribution of drugs

• -Note Items 1-5

• -Item 4 Positive ID of person receiving drug if controlled substance

• -Records of administration to contain items (D)(5)(a)-(e)

4729-17-05
Controlled substance recordkeeping

(A) Greater than 72-hours dispensed

-tamper-evident, unit-of-use containers

-stored in a secure location

-proof-of-use sheet or other board-approved recordkeeping system

-positive identification of wastage

-a reconciliation every change of shift,

Controlled substance recordkeeping

• Floor stocks - no secure, automated storage system

• Must meet the requirements of (B)

– See Items 1-4 listed under section B

Controlled substance recordkeeping

• Floor stocks - secure, automated storage system

• Must meet the requirements of (C)

– See Items 1-6 listed under section C

4729-17-08 Minimum Standards

(A) Library

(B) Drug inventory, fixtures, space

4729-17-09 Drug orders for inpatients

(A) -Drugs to be dispensed pursuant to a patient specific order

-Oral orders are permitted - need positive ID of person

-Faxes allowed- Policies to state who can fax

Drug orders for inpatients

B. Drug orders to contain

Name of patient

Name, strength & dosage form of drug

Directions & route if not oral

Date prescribed

Prescriber’s positive ID

C. Outpatient orders. Same rules as retail prescriptions.

D. Schedule II orders for long term care patients - fax permitted

4729-17-10 Labeling

(A)(1) Unit dose labeling

- non proprietary or proprietary name of drug

-Route

-Strength and volume

-Control number & expiration date

-ID manufacturer or if repackager is pharmacy then name or last 6 digits of TDDD license number

(A)(2) Multiple dose labeling

Dispensed in a container labeled with

- ID of dispensing pharmacy

- Patient’s name

- Date of dispensing

- non proprietary or proprietary name of the drug

- Strength

And Still More Labeling

(C) Parenteral solution labeling

- Patient’s name

- Name & amount of parenteral solution

- Name & amount of drug

- Expiration date

- Name & address of pharmacy

- Cautions

4729-17-13 DEA Numbers for hospital employed practitioners

If prescriber does not have personal DEA # may be assigned one through hospital

Must be involved in scope of training or employment with hospital

Use hospital DEA # plus suffix

Example AM 1234567-A588

Number to be kept on file by hospital

Consult Agreement Chapter 4729-29

4729-29-01 Reasonable attempt to contact and confer.

• Notification of intended action

• provides the physician with the opportunity to respond in a timely manner

Such notification may include

(A) Personally meeting with the physician;

(B) Telephone discussion with the physician;

(C) Facsimile in a manner that confirms delivery;

(D) Electronic mail that confirms delivery;

(E) Any other method in writing that reaches the physician in a timely manner; or

(F) Any other method of notification as outlined in the consult agreement

4729-29-02 Pharmacist as agent

• If the consulting pharmacist is not the dispensing pharmacist or the person administering the dosage ordered, the consulting pharmacist shall be deemed to be acting as the agent of the consulting physician as the term agent is used in rule 4729-5-30

4729-29-03 Records

1. All consult agreements and the records of actions taken pursuant to such consult agreements shall be in writing

2. Maintain these records for at least three years from the date of the last action taken

3. Shall be considered confidential patient records

4729-29-04 Therapy management by formulary

• Consult agreements not necessary within an institutional facility as defined in rule 4729-17-01 of the Administrative Code when the pharmacists are following the requirements of a formulary system.

4729-29-05 Signatures required on a consult agreement

• consult agreement must bear the signatures of one patient or caregiver, one physician, and one pharmacist

• consult agreement must define the diagnosis or diagnoses that affect the drug therapy that is covered by the agreement

• group of physicians or pharmacists who may be caring for the patient, the consult agreement shall be signed by the primary physician and the primary pharmacist

Chapter 4729-31 Fluid therapy pharmacy

4729-31-02 Prescriptions for sterile products

Oral, written and fax orders permitted

C) All drug orders for patients of a fluid therapy pharmacy shall include

C) All drug orders for patients of a fluid therapy pharmacy shall include

(1) Name and address of the patient;

(2) Name, strength, and dosage form of the drug;

(3) Directions for use, including route of administration if other than oral;

(4) Date prescribed;

(5) Prescriber's positive identification;

(6) Length of therapy or total quantity to be dispensed.

4729-31-03 Labeling
Each prescription label to contain

(A) The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

(B) The name of the patient for whom the drug is prescribed;

(C) The name of the prescriber;

(D) Directions for use of the drug which must include route of administration;

(E) The date of dispensing;

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

(G) The name or initials of the pharmacist;

(H) The name and amount of the drug(s) added;

(I) The name and volume of the parenteral solution;

(J) The quantity of drug dispensed, if appropriate;

(K) Beyond use date;

(L) Storage conditions.

4729-31-04 Recordkeeping

(A) A record of all drugs purchased

(B) All drug orders and records relating to the practice of pharmacy

(C) A record of all drugs compounded

(D) All records must provide accountability

Must be maintained for 3 years.