Ohio Board of Pharmacy Regulations
- Pharmacy Practice-Internship (Chapter 4729-3)
- Pharmacy Practice - Administration (Chapter 4729-05)
- Pharmacy Practice—Impaired Pharmacists (Chapter 4729-6)
- Pharmacy Practice—Continuing Education (Chapter 4729-7)
- Dangerous Drugs (Chapter 4729-9)
- Nonresident Terminal Distributor of Dangerous Drugs (Chapter 4729-10)
- Controlled Substances (Chapter 4729-11)
- Ephedrine (Chapter 4729-12)
- Institutional Facilities: Drug Control (Chapter 4729-17
- Fluid Therapy Prescriptions (Chapter 4729-19)
- Peritoneal Dialysis Solution Prescriptions (Chapter 4729-27)
- Consult Agreements (Chapter 4729-29)
Pharmacy Practice-Internship (Chapter 4729-3)
4729-3-01 Definitions
4729-3-02 Registration as a pharmacy intern
4729-3-03 Application for registration as a pharmacy intern
4729-3-04 Pharmacy intern identification card renewal
4729-3-05 Internship credit
4729-3-09 Expiration of pharmacy intern registration
4729-3-01 Definitions
- (A) "Pharmacy internship"
- (B) "Supervised practical experience"
- (C) "Internship site"
- (D) "Preceptor"
- (F) "In good standing"
- (G)"Statement of Preceptor"
4729-3-01 Definitions (Cont.)
- (H)"Practical experience affidavit"
4729-3-02 Registration as a pharmacy intern
- Intent of registration
- Qualifications
- 4729-3-03 Application for registration as a pharmacy intern
- 4729-3-04 Pharmacy intern identification card renewal
- 4729-3-05 Internship credit
- No credit before registration
- Statement of preceptor form
- Submit PEA’s by March 1 of following year
- Pharmacy Practice – Administration (Chapter 4729-05)
- 4729-5-01 Definitions
- 4729-5-02 Identification card
- 4729-5-03 Renewal of registration
- 4729-5-04 Violations as evidence of denial
- 4729-5-01 Definitions
- (A) Practice Pharmacy
- (B) Dispense
- (C) Compound
- (D) Interpret prescriptions
- (I) Personal supervision
- (J) Preprinted order
- (L) Protocol
- (M) Prescriber
- (N) Positive identification
4729-5-02 Identification Card
- Must be signed.
- Photo no longer required
4729-5-03 Renewal Of Registration
ID card must be renewed every year by September 15
4729-5-04 Violations as evidence of denial
- Felony
- Violation of pharmacy or drug law
- Moral character or habits
- Addicted or abusing
4729-5-05 Name change
Report name change within 60 days See details
4729-5-06 Report change of address or place of employment
Within 30 days
4729-5-09 Prescription Filing
- Three files
- Schedule II
- Schedule III,IV and V
- Non-controlled drugs
4729-5-11 Responsible Pharmacist
- Only a pharmacist may be a responsiblee person.
-Cannot be responsible pharmacist for moore than 1 location
4729-5-11 Responsible Pharmacist (cont)
- Need board approval for more than 1 loocation
- Change in responsible pharmacist to bee reported within thirty days
4729-5-13 Prescription Format
-Must comply with 4729-5-30
-Preprinted forms are permitted for multtiple drugs if
- no controlled substances
-one prescription per form
- (See examples)
Format for controlled substance prescriptions
-4729-5-30
-One prescription per form
-Quantity written both numerically and aalphabetically
4729-5-13 Prescription Format
Format for controlled substance prescriptions (cont)
-If preprinted, only one drug and strength per form
-Remember rule for residents and staff physicians
4729-5-15 Prescriber
- Dentist
- Optometrist
- Physician, osteopath, podiatrist
- Veterinarian
- Advanced practice nurse
- Non resident practitioner
4729-5-16 Labeling
- Name and address of pharmacy
- Name of patient
- Name of prescriber
- Directions
- Date of dispensing
- Cautions
- Serial(Rx) number
- Name or initials of RPh. -DELETED
- Trade name or generic name and name of distributor
- Quantity dispensed
- Special rules for small containers
- Rx number & name of patient
4729-5-17 Prescriber Labeling
- (A) Dangerous drug other than a sample
- See items 1-5
- (B) Samples furnished to patients.
- If directions different than container must label with
- Name of prescriber, patient, and directions
4729-5-18 Patient profiles
- Be familiar with information required for patient data record and drug therapy record
- Profile shall be maintained for one year after last entry in profile
4729-5-19 Serial numbering of prescriptions
- Serial number must appear on prescription
- Must be complete and consecutive
- Prescriptions with no refills must be assigned a new serial number
- Addditional refills OK within time period. Must be noted on original Rx
- See division D for requirements for central filling operations
4729-5-20 Prospective Drug Utilization Review
- Before dispensing, RPh shall review patient profile for items listed
- If any problems encountered RPh to take appropriate action
4729-5-22 Patient Counseling
- Pharmacist or designee shall personally
- Offer to counsel
- To patient or caregiver
- New or Refill
- If counseling refused then refusal to be documented
- Written offer if patient not present
4729-5-22 Patient Counseling
- Pharmacist or intern must counsel patient
- See items listed in 4729-5-22
- Other forms of drug therapy information may used to supplement counseling.
4729-5-24 Prescription Copy
- Copies transmitted only between pharmacists
- Copy transferred
to contain
- Rx number
- Name, address of transferring pharmacy & DEA number if controlled substance
- Original date of Rx
- Original Date of Dispensing
- Original # of refills
- Date of last refill
- Refills remaining
- Name of transferring pharmacist
- Note federal law requires date & location of each refill for CS
- Write "TRANSFER" on face of Rx and date of transfer
- Transferring copy
to contain:
- Original Rx must have "VOID" written on face
- Reverse of Rx to contain(note computer reqs)
- Date of transfer
- Signature of transferring pharmacist
- If oral copy, record name of RPh, and name & address of pharmacy (DEA of pharmacy if CS)
- Computer systems have different requirements
- Prescription record must contain
- Date of transfer
- Name of transferring pharmacist
- Name and address of receiving pharmacy
- Controlled substance prescriptions must comply with division A and B of this rule
- Pharmacies with central database may transfer copies. Not considered copy (F)
- Prescription copies may be transferred by fax machine. Keep in mind positive identification requirements of transferring and receiving pharmacists.
- (E) Prescriptions not filled. May be transferred but must be entered into computer first. See requirements 1-5.
4729-5-25 Dispensing and compounding
- Only pharmacist or intern is permitted to dispense or compound
- Others may assist pharmacist,
- Pharmacist is responsible for drug dispensed
- System must assigned responsibility to pharmacist
4729-5-26 Partial dispensing of Schedule II drugs
- Much the same as federal regulations
- Only for terminal patients or patients in long term care facility
- Note record keeping requirements
- All partial dispensing to occur within 60 days
4729-5-27 Recordkeeping
- Long, technical regulation
- (A) positive ID required for all activities related to practice of pharmacy
- For original prescription pharmacist must record date and manually record initials or if approved by board may use computerized positive ID
- Be aware of different methods of keeping track of refills(Slide 44)
- If written for generic, either brand name or generic name and distributor must be recorded on face of prescription.
- Note section F. Patient not to receive more drug than intended
- Note section (D) & (G)(4) If larger quantity dispensed. MD approval must be obtained
- Be aware of all of division (G) requirements
- Keep for three years
4729-5-28 Computerized record Keeping Systems
- Longest regulation
- Immediate retrieval of last twelve months prescriptions
- Three day retrieval of prescriptions from previous 36 months
- FOUR
ways of keeping refills records
- Positive Identification (remember definition)
- Computer generated printout signed by all pharmacists
- Tamper evident log
- Tamper evident log w signature at end of day
- Various printouts may be required
- Know procedure for down time
- Purged records must be maintained for 36 months
- System must produce audit trail
- Remember a computer password alone does not qualify as Positive Identification.
4729-5-29 Confidentiality of patient records
- Rx records are not public record
- Cannot be released to anyone except those listed.
- Records may be released to authorized law enforcement officials. They must provide receipt.
4729-5-30 Manner of Issuance of Rx
Most important rule for retail pharmacists.
(A) Rx must be for legitimate medical purpose
Usual course of his/her professional practice
All written prescriptions must be manually signed by prescriber
(B) All prescriptions issued by a prescriber shall:
(1) Be dated as of and on the day when issued.
(2) full name and address of the prescriber.
(3) full name and address of the patient.
(4) drug name and strength.
(5) quantity to dispense.
(6) appropriate directions for use.
(7) Specify the number of refills or the period of time for which the prescription may be refilled.
A prescription marked "Refill P.R.N." is not valid
(8) Not authorize any refills for schedule II controlled substances.
(9) Authorize refills for schedules III and IV controlled substances (5 refills or 6 months
(10) Refills for schedule V controlled substances and for dangerous drugs that are not controlled substances for only one year
(11) Identify the trade name or generic name of the drug(s) in a compounded prescription
(12) Not be coded
(13) For prescriptions issued to a patient by a prescriber, be:
(a) Manually signed on the day issued
(b) Issued in compliance with rule 4729-5-13
(C) Multiple copies - original stays w pharmacy
(D) No dispensing a dangerous drug for the first time beyond six months from date written
(E) Oral rx’s to:
(1) A pharmacist
(2) A recording device
- A licensed pharmacy intern
(F) Fax Rx’s must comply w the following:
- not be issued to the patient
- positive ID of the prescriber and his/her agent as well as positive identification of the origin of the facsimile.
- Prescriptions for schedule II controlled substances may not be transmitted by facsimile except:
- (a) Pursuant to rules 4729-17-09 and 4729-19-02 of the Administrative Code.
- (b) Faxes permitted for hospice patients. The original prescription must indicate that the patient is a hospice patient.
A fax must be sent directly from the prescriber or the prescriber’s agent. Faxes from other pharmacies are considered copies and must comply with rule 4729-5-24 of the Administrative Code.
(G) Electronic prescriptions OK If:
board-approved and
(1) The system shall require positive identification of the prescriber as defined in rule 4729-5-01 of the Administrative Code and the full name of any authorized agent of the prescriber who transmits the prescription.
(2) The computer data retained for three years at the prescriber's office.
(H)Consult agreement Rx’s
- See text of rule for requirements
4729-5-31 Criteria for licensure by examination
- Must store 75 on NAPLEX exam and 75 on jurisprudence exam
- If license lapsed for three years must meet above requirements.
- NEW -
A CANDIDATE MAY TRANSFER HIS/HER NAPLEX SCORE TO OHIO
4729-5-35 Automated drug delivery systems
- Must receive prior approval from pharmacy board.
- Must maintain on-going quality assurance programs