Ohio Laws

Ohio Laws

Ohio’s Food Drug and Cosmetic Act (Chapter 3715)

Passed by the Ohio Legislature

Amended at various times through the years

Deals with same subject matter as Federal Food Drug & Cosmetic Act with some changes and additions

Sec 3715.01(A)(16)
Generically equivalent drug

1.Identical amounts of the identical active ingredient

2.same compendial standards, same disolution rates

3.cannot have proven bioequivalence problems in Orange Book

4. A generic drug is not required to be in a dosage form identical to that of the brand name drug.

Sec 3715.53

Temporary or permanent injunction

OHIO’S CONTROLLED SUBSTANCES ACT (Chapter 3719)

Ohio’s law dealing controlled substances
Most sections mirror the Federal CSA

Section 3719.021
Persons other than a licensed manufacturer, pharmacist, or owner of a pharmacy who possess for sale, sell, or dispense controlled substances at wholesale shall first obtain a license as a wholesaler of controlled substances from the state board of pharmacy.

Sec. 3719.04
(A) A licensed manufacturer or wholesaler of controlled substances may sell at wholesale, controlled substances to any of the following persons and subject to the following conditions:

1.May sell to licensed manufacturer

2.May sell to licensed wholesaler

3.May sell to licensed terminal distributor having a category III license

Sec. 3719.05

Rules for pharmacists dispensing controlled substances

See parts (A)(1) to (A)(5)

Sec. 3719.06

This sections applies to prescribers

Conditions for prescribing, dispensing or administering controlled substances

Note parts (B) relating to anabolic steroids

and (C) - prescription requirements
Section 3709.07
Records of Controlled Substances Handled

Applies to prescribers

Every licensed health professional authorized to prescribe substances shall keep a record of all controlled substances received and a record of all controlled substances administered, dispensed, or used other than by prescription.

Records to Include

1.The description of all controlled substances received, the name and address of the person from whom received, and the date of receipt

2.The description of controlled substances administered, dispensed, purchased, sold, or used; the date of administering, dispensing, purchasing, selling, or using; the name and address of the person to whom, or for whose use, the controlled substance was administered, dispensed, purchased, sold, or used (3709.07(b)(1) and (4)
Section 3719.08 Labeling

(B) Pharmacist to label properly

(D) A licensed health professional authorized to prescribe drugs who personally furnishes a controlled substance to a patient shall comply with division (B) of section 4729.29

Sec. 3719.121

License to be suspended if addiction occurs

Sections 3719.15 and 3719.16 The sale of exempted drugs

3719.15 Preparations exempted -See parts (A)(1) to (A)(6)

3719.16 Sales in 48 hours

Sec. 3719.172

(A)Hypodermics - Who can possess?

Not to be displayed

Can be sold by others

Someone under RPh supervision

3719.43

Ohio schedules change automatically when federal schedules change

Sec. 3719.44

Board’s authority to modify CS schedules

Add

Transfer

Remove

Follow criteria set out in division (B)

Exempted Ephedrine Products

Part (K)(1) List ephedrine containing products that are exempted from Schedule V

Sec. 3719.81
Illegal use of drug samples

Samples OK if:

Directly to patients

Original container

Stored under proper conditions

Expiration date

Keep away from unauthorized persons

OTC drugs exempted

Emergency Medical Services

1. Ordering of controlled substances by Emergency Medical Services

2. For schedule II substances must use form 222

3. For exchange for Schedule II substances used see Board Policy Resolution 90-080 and the exchange form

Confidentiality in Pharmacy Practice

Professional Liability Insurance

What is professional liability insurance?

If you are employed by a large chain of pharmacies or a hospital do you need to carry professional liability for yourself or can you rely on your employer's insurance.

Home much does professional liability insurance cost and where can you obtain it?

How much coverage do you need ands what acts are covered?

What about intentional criminal acts?