Pharmacy Practice- Continuing Education (Chapter 4729-7)

4729-7-01 Definitions
(B) C.E.U. - Continuing education unit - 10 contact hours
(C) Approved C.E. - CE presented by an approved provider
(D) Approved provider - Approved by Rx Board or ACPE

4729-7-02 Requirements for renewal
 1. 6.0 CEU’s (60 hours) every 3 years
2. 0.3 CEU’s(3 hours) of Rx Jurisprudence
3. Must be obtained in 3 year period preceding 7/1 of year of reporting
4. Extra cannot be carried over.
5. Maintaining CE & licensed in another state can renew in Ohio. See Statement.

4729-7-02 Requirements for renewal (More)

6. At least 4 1/2 C.E.U.s(45 hrs) of the total required C.E.U.s must be obtained in patient care related programs.

4729-7-08 Alternative methods of proving continuing competency.

1. Currently certified by a board approved pharmacy practice specific specialty certification program.

2. Such certification programs shall consist of:

(1) Periodic recertification examinations;

(2) Documentation by the certification program that the pharmacist is currently certified by the program;

(3) Other requirements as determined by the board.

4729-7-03 Evidence of CPE Experiences
Keep certificates

Dangerous Drugs
(Chapter 4729-9)

4729-9-01 Definitions
(A) Dangerous drug
(B) Adulterated - drug is adulterated if beyond expiration date.
(E)Revoke, (F)suspend, (G)place on probation

4729-9-02 Minimum standards for a pharmacy.
(A) Library ****
(B) Equipment
(C) Drugs
(D) Rx containers
(E) Space and fixtures

4729-9-04 Returned Drugs
Drugs may not be returned after having left premises except for
- Inpatients in tamper evident containers
- Or on certain outpatient facilities

4729-9-05 Security Requirements
Registrants are to maintain effective procedures to guard against theft and diversion.
-Substantial compliance means:
Review 14 points in regulation - New systems or changes to be reviewed and approved by board

4729-9-06 Disposal of Dangerous Drugs which are Controlled Substances
Very similar to federal regulation.
(A)(2) Submit letter to Rx Board & request permission to dispose of C.S.
Board will respond - transfer, destroy or other instructions.
May give permission to regularly dispose. See division (C) of regulation

4729-9-07 Discontinue business as Terminal Distributor
Notify board in writing 14 days in advance.
Do complete inventory on date of discontinuing business

4729-9-08 Change in description of Terminal Distributor
Notify board of any change in name, ownership or address of terminal distributor

4729-9-09 Security of prescription blanks and DEA form 222
 4729-9-10 Occasional sale - Wholesale sale by a terminal distributor.
Total value shall not be >5% of total value of all DD’s sold in calendar year. Value based on cost of drugs
Do not confuse w Fed CS reg

4729-9-11 Security and control of dangerous drugs
R.Ph. to provide supervision and control according to division (A)
-Personal supervision by R.Ph.
-If no R.Ph. then follow (2)(a)-(g)
-Note (A)(3)
-And Note also Division(C)

4729-9-12 Verification of license of terminal distributor and wholesaler.
Wholesaler to see copy of Term. Dist. certificate
Term. Dist. to get registration number of wholesaler.

4729-9-13 Distributor of Dangerous Drug Samples
 Must be registered as wholesaler

4729-9-14 Records (relates to controlled substances)
-(A) Records for CS’s received, administered, or dispensed.
-(B) Must do inventory. Similar to DEA inventory.
-(C) Separate inventory for each location
-Other requirements similar to federal regulation.

4729-9-15 Report of theft of dangerous drugs, controlled substances and drug documents.
Notify authorities of (any) theft or significant loss of any dangerous drug or CS.
Notify Ohio board immediately by telephone
Theft of CS use form 106

4729-9-15 Report of theft(Cont)
Form 106 to be filed with board within thirty days
Must also report any theft or loss of Rx blanks and form 222’s immediately.

4729-9-17 Storage of adulterated drugs
 Adulterated drugs shall be stored separately.
Can only be kept for one year.(2 years for wholesalers)
4729-9-18 Licenses to be readily available

4729-9-20 Repackaged drugs
 (A)Labels to contain:
-Name of drug, strength & dosage form
-ID of repackager by name or last 6 digits of TDDD registration
-Pharmacy control number
-Pharmacy expiration date (Cannot be later than mfg. expiration date)
(B)Records of prepacks must be maintained. See division (B) for details)

4729-9-21
Drugs compounded in pharmacy
 -Pharmacist shall inspect & approve process
-Pharmacist shall be responsible for all records and maintenance & use of equipment.
Limited quantity of may be compounded in advance

Compounded Drugs

(B) Parenteral and sterile product prescriptions shall be compounded in accordance with Chapter 4729-19

(H) Labels for a compounded prescription that is prepared in anticipation of a prescription drug order shall contain, information set out in (1)-(4)

4729-9-22 Records of dangerous drugs (Not controlled substances)
- Need records of receipt
- Need records of administering and dispensing.
-Keep for three years.