Laws in the United States come from various sources. From the United States constitution and various states constitutions, from laws legislation passed by Congress and the various state legislatures, from regulations passed by federal and state agencies such as the DEA, FDA, Ohio Board of Pharmacy, and finally law developed through court decisions.

Some areas of life are exclusively controlled by state law. An example of this would be the registration of pharmacists, physicians, and nurses in each state. Some areas are governed exclusively by Federal law - such as postal regulations, but other areas can overlap. Both the federal government and the state can pass laws and regulations dealing with the same area. An example of this would be controlled substances. They are regulated by both the Pharmacy Board of a state and by the Federal Drug Enforcement Administration.

An individual can get in trouble in several different areas from committing just one act. A pharmacist can incur criminal, civil and administrative liability from on illegal act. An example would be selling a Schedule II drug without a prescription where the purchaser died from an overdose. The pharmacist could be prosecuted for trafficking (criminal), sued for damages for wrongful death (civil) and the pharmacy board could revoke his or her license (administrative).

1. Food and Drug Act of 1906
   Prohibited Adulteration and Misbranding of Drugs
   Misbranding was defined as "false and fraudulent".

 

2. The Federal Food, Drug and Cosmetic Act of 1938
   Proof of false and fraudulent no longer required.
   Court injunctions and factory inspections authorized
   Premarket approval based on safety required

 

3. Durham-Humphrey Amendment of 1951
   Established the status of prescriptions drugs

 

4. The Drug Amendments of 1962
   Premarket approval for efficacy required
   Broadened investigational new drug requirements
   Record keeping requirements
   Required GMP'S
   Drug Efficacy Study Implementation (DESI) Review
   OTC Drug Review

 

5. Orphan Drug Act of 1983
   Created Status of Orphan Drugs
   Provided Tax Credits and Market Exclusivity for Developing Orphan Drugs

 

6. The Drug Price Competition and Patent Restoration Act of 1984
   Abbreviated new drug applications (ANDA)
   Paper NDA'S
   Patent extensions for portion of patent term lost while drug was in regulatory review

8. Prescription Drug User Fee Act
   User Fees

What are they?

 

Who pays them?

 

How much?

 

 

9. Generic Drug Enforcement Act of 1992

Recent developments in the review and approval of new medications
by Gerald Gianutsos

• Fast Track -
• Treatment IND'S
• Parallel Tracks
• Accelerated Approval
• Orphan Drugs

Treated later

• Label
• Labeling
• Misbranded
• New Drug

If drug is not considered a prescription drug than it can be sold as an OTC drug.

Can OTC drugs be sold without an approved NDA?

Is Pre-market clearance required?

Monograph system.

Four-step process by which classes of drugs are evaluated to see if they are Generally Recognized As Safe and Effective (GRASE) and recommendation made regarding their use and labeling, packaging etc.

Twenty different classes of drugs have been found to not be (GRASE) and therefore are new drugs.

Switch from prescription status to OTC status.

1. Switch regulations - restrictions imposed at the time of approval that require warnings to consumers
2. Supplemental NDA's or ANDA's
3. Inclusion in OTC monographs of drugs previously available only by prescription

Note that even though pre-market approval is not required for monograph OTC drugs, the manufacturers still must comply with CGMP's.

1. Name
2. Name and address of Manufacturer, Packer, or Distributor
3. Net Contents of the package
4. Established name of all active ingredients and some other ingredients
5. Name of any habit forming drugs
6. Cautions and Warnings
7. Adequate directions for safe and effective use

Adequate directions for use

1. Warnings
2. Tamper resistant packaging
3. Pregnancy Warning
4. Federal labeling requirements

Prohibitions related to adulterations

Definition of adulterated drug

Contains filthy, putrid or decomposed substances

Does not meet standards for strength, quality and purity

Not manufactured in accordance with GMP'S

Currents Good Manufacturing Practices (CGMP)

Prescription Drugs - Labels compared to labeling

Label - Affixed to the container

Labeling - all labels, package inserts, ads in journals and all other promotional material.

False or Misleading Labeling

Name of Drug

Name and Place of Business of Manufacturer, Packer, or Distributor

Ingredients

Adequate Directions

Warnings

1. Name of Manufacturer, packer, or distributor
2. National Drug Code (NDC) number requested but not required
3. Adequate directions for use
4. List of ingredients
5. Expiration dating. What does month/year mean?
6. Control Number

1. Established name of the drug
2. Net quantity of contents
3. Statement of recommended usual dosage

Labeling must contain: (Package Insert)

1. Name and address of dispenser (Pharmacy)
2. RX Number
3. Date of filling
4. Name of Prescriber
5. Name of patient
6. Directions
7. Cautionary statements

(Remember that Ohio also has regulations for labeling that we will discuss later)

The label of the drug bears:

(7) A statement directed to the pharmacist specifying the type of container to be used in dispensing the drug product to maintain its identity, strength, quality, and purity.

The CGMPS are extensive regulations that all manufacturers must comply with. If the FDA finds that the CGMPS have not been complied with then entire batches of drugs can be declared adulterated by the FDA. Pharmacies that compound large batches of drugs could be determined by the FDA to be manufacturing and therefore must comply with the CGMPS.

The Prescription Drug Marketing Act of 1987

Prohibits:

• Reimportation
• Sale or trade of samples. Physicians must request samples and drug reps must keep records of requests and distribution of samples.

• Hospitals from reselling Rx drugs.
• Wholesalers must be licensed with the states in which they do business

Questions about samples (Module Eleven)

Pay particular attention to Answers #2 and #4

Drug Recalls (Module Four)

Excerpt form FDLI Fundamentals of Law and Regulation

The removing from the market of a drug product that may be misbranded, adulterated, or otherwise in violation of the law

A "voluntary" act by the manufacturer.

FDA can seize product or take other enforcement action if manufacturer refuses to issue recall.

Class I - Most serious. Serious adverse health consequences or death. Issued to general public.

Class II - Temporary or reversible adverse health consequences.

Class III - Not likely to cause adverse health consequences.

Market Withdrawal - Minor health risk or violation.

Depending on seriousness.

To wholesaler

To retailer

To consumer

In the future, Dietary Supplements are going to be an even larger part of the pharmacist's practice then they are now. Dietary supplements include various vitamins, natural herbs, and other products that are not considered drugs. The main characteristic that distinguishes dietary supplements from drugs is that they do not intend to diagnose, treat, cure, or prevent any disease.

Overview of Dietary Supplements

An FDA Guide to Dietary Supplements

Sample Dietary Supplement Label

Dietary Supplement Health and Education Act of 1994

FDLI Dietary Supplements (Module Six)

Current Good Manufacturing Practices (CGMP'S)

FDLI Compounding and Manufacturing (Module Two)

Definitions

Compounding - mixing of two drug together pursuant to a prescription.

Manufacturing - the mixing together of larger quantities of drugs

• Not always pursuant to a prescription.

Allowable compounding activities:

• Preparation of limiting quantities in advance when there is a history of receiving prescriptions.

Factors that change compounding to manufacturing.

• Promoting products to physicians
• Promoting and distributing products to other pharmacies, wholesalers and/or consumers

Effects of an activity being determined to be manufacturing.

• Lose Rx labeling exemption
• Subject to CGMP'S

Prescription only "legend" revised

R.Ph. Compounding

FDLI Off-labeled uses of Approved Drugs (Module Eight)

Promotional Material Review Process Flow Chart

Only indications approved by the FDA can appear in the official labeling of a product.

What if a physician prescribes a drug for an unapproved indication? Can you fill the prescription?

Can a detail representative of a drug company promote a drug product for an unapproved use?

If a patient is injured as a result of taking a drug dispensed pursuant to prescription written for an unapproved indication , who is liable? Why?

Only drug products that are considered to be therapeutically equivalent can be used to substitute one drug product for another.

"A" rated drugs are considered to be therapeutically equivalent

"B" rated drugs are considered not to be therapeutically equivalent

Must be distributed with every dispensing

• Exception for institutional patients (Every 30 days)

Requires that various substances (Sec1700.14) and all oral prescription drugs must be dispensed or sold in childproof containers.

Exceptions for following prescription drugs:

Prescription drugs. Any drug for human use that is in a dosage form intended for oral administration and that is required by Federal law to be dispensed only by or upon an oral or written prescription of a practitioner licensed by law to administer such drug shall be packaged in accordance with the provisions of Sec. 1700.15 (a), (b), and (c), Exceptions are made for certain drug products that are listed as follows

In certain instances the pharmacist does not have to dispense a drug in a complying container. Either the patient or the physician can waive the requirement of a childproof container.

Differential pricing among competitors prohibited.

Differential pricing means that certain classes of non-competing pharmacies can purchase drugs at much cheaper prices than other pharmacies. However those pharmacies - usually hospital pharmacies - cannot dispense those drugs to patients who would usually be purchasing their medications from retail pharmacies. This would be anti-competitive in that the hospital pharmacies could sell the drugs at much cheaper prices than the retail pharmacies and still make a profit.

Own Use doctrine

The exception to the above is the own use doctrine that allows hospital pharmacies in certain circumstances to dispense drugs to outpatients and others.

See Abbott Labs v. Portland Area Retail Druggists Supreme Court Case

OTC manufacturers must package all products in tamper resistant packaging.

1. Controlled Substances Act 1970
2. Administered by DEA part of Justice Department
3. Classified drugs according to schedules
4. Establishes closed system of drug distribution

Illegal drugs

No known medical use

1. high potential for abuse
2. currently accepted medical use
3. severe physical or psychological dependence

1. high abuse potential but less than I or II
2. accepted medical use
3. moderate or low physical dependence or high psychological dependence
4. know limits on certain schedule III drugs

1. low potential for abuse relative to schedule III
2. accepted medical use
3. limited phys. and psyc. dependence compared to schedule III

1. low abuse potential
2. accepted medical use
3. limited phys. or psyc. dependence relative to schedule IV
4. know limits on certain substances

1. Federal Level – DEA
2. State Level- Up to States Ohio - Pharmacy Board or Legislature

Practitioners - MD’s. DDS’s
-Pharmacies, Wholesalers
-Individual pharmacists exempt
-Note exemptions for hospital or individual practitioners

Exemption of certain military and other personnel.

1. Identification Symbols
2. C-II or C with schedule designation inside

RECORDS OF DRUGS:
1.DISPERSED

2.RECEIVED
3.INVENTORIES
KEEP FOR TWO YEARS

Inventory Requirement
1. All Controlled substances
2. Every two years
3. At beginning or end of business
4. Sch II exact count
5. Others estimate except for bottles >1000
6. Remember newly scheduled drugs

1. Schedule II drugs - Use third copy of DEA form 222.
2. Sch III, IV & V drugs. Invoices from wholesaler are acceptable. Invoices containing both controlled and non-controlled drugs must be identified in some notable manner.

1. Prescriptions,
2. record books,
3. Form 222,
4. invoices,
5. med orders,
6. records of destruction & theft and loss

Prescription files - three options Section 1304.04
1. Three files:(This is the mandatory option for Ohio)
Sch II
Sch III, IV & V
Non controlled drugs
2. Two files:
Sch II
Sch III, IV & V & non controlled drugs w controlled drugs marked w Red C
3. Two files:
All controlled drugs - III, IV & V with RED C
Non controlled drugs in separate file
Red C not required if computer can retrieve information

Filed Prescriptions
1. Dated when written (issued)
2. Name & address of patient
3. Name & address & DEA # of practitioner
5. Date dispensed and number dispensed
6. Written or typewritten name of dispenser
(Ohio requires written initials)

See copy of form

1. Can only be used for Sch II drugs
2. Execution details
3. Name & address of Supplier
4. Can only be signed by person who signed for CS registration or person w Power of Attorney (See page 191)
5. Don’t forget to complete Copy 3 and keep.

(1) Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and

(2) Either registered or exempted from registration pursuant to Secs. 1301.24(c) and 1301.25 of this chapter.

Advanced Practice Nurses (APN) and Prescriptive Authority

Conditions allowing an APN to prescribe

Ohio State Medical Board - Self and Family Prescribing

1. Legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice
2. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients
3. A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for ``detoxification treatment'' or ``maintenance treatment''

Add first, third and fifth digits

Adds the sum of the second, fourth, and sixth digits multiplied by 2 and adds to first sum

Determines if the right most digit corresponds with the ninth check digit.

AN 1257218

1 + 5 +2 = 8

(2 + 7 + 1) x 2 = 20 then 20 plus 8 = 28

The 8 of 28 is the same as the ninth digit of the DEA number

1. Dated as of, and signed on, the day when issued
2. Bear the full name and address of the patient
3. Drug name, strength, dosage form, quantity prescribed
4. Directions for use
5. The name, address and registration number of the practitioner
6. Sign a prescription in the same manner as he would sign a check or legal document
7. If an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner

The registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution

Sec. 1306.06 Persons entitled to fill prescriptions. A pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy

Usually only written prescriptions are allowed

Exceptions are:

1. Emergency situations (Oral rx's permitted) see division (d) to follow
2. IV administrations (Faxes permitted) see division (e) to follow
3. Long Term Care Facility (Faxes permitted) see division (f) to follow
4. Patient residing in a hospice certified by Medicare (Faxes permitted) see division (g) to follow

• Immediate administration necessary
• No appropriate alternative treatment available

Not possible for prescriber to provide written Rx

1. Quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period
2. The prescription shall be immediately reduced to writing by the pharmacist
3. Must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner
4. Within 7 days the prescribing individual practitioner shall cause a written prescription to be delivered to the dispensing pharmacist

The refilling of a prescription for a controlled substance listed in Schedule II is prohibited

1. Permitted
2. If the pharmacist is unable to supply the full quantity (Only reason)
3. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

1. M.D. must certify patient terminally ill
2. Notation must be made on the prescription
3. Partial fillings allowed for up to 60 days
4. Total quantity cannot exceed amount RX written for
5. Computerized recordkeeping allowed

Affix to the package a label showing

1. date of filling,
2. the pharmacy name and address,
3. the serial number of the prescription,
4. the name of the patient,
5. he name of the prescribing practitioner,
6. directions for use
7. cautionary statements.

Above does not apply

When a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized: Provided, That:

(1) Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time;

(2) The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration;

(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient

1. written prescription signed by a practitioner
2. a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner's agent to the pharmacy
3. an oral prescription

1. Can be refilled for up to six months from date of issuance or
2. Up to 5 refills whichever comes first

Prescriber may authorize additional refills as long as the refills do not exceed the 6 month or 5 refill limitation

Recordkeeping of refills

Note refills on back

Computerized records allowed

Must printout list of controlled substance Rx's and sign or

Maintain logbook

If computer goes down, have auxiliary procedure available. Enter in computer as soon as it comes back up.

1. Each partial filling is recorded
2. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed
3. No dispensing occurs after 6 months

Pharmacist shall affix to the package a label showing

1. the pharmacy name and address,
2. the serial number
3. date of initial filling, **************** (Federal law for all rx's requires date of current filling)
4. name of the patient,
5. the name of the practitioner issuing the prescription,
6. directions for use
7. cautionary statements,

For institutions use the following

Above requirements do not apply provided that the patient is institutionalized and

(1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III or IV is dispensed at one time;

(2) The controlled substance listed in Schedule III or IV is not in the possession of the ultimate user prior to administration;

(3) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III or IV; and

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product and the patient, and to set forth the directions for use and cautionary statements

1. one time basis only (Except for pharmacies sharing a real-time on-line database)
2. communicated directly between two licensed pharmacists

1. Write the word ``VOID'' on the face of the invalidated prescription.
2. Record on the reverse of the invalidated prescription the name, address and DEA registration number of the pharmacy to which it was transferred
3. the name of the pharmacist receiving the prescription information.
4. Record the date of the transfer and the name of the pharmacist transferring the information.

The pharmacist receiving the transferred prescription information shall reduce to writing the following:

1. Write the word ``transfer'' on the face of the transferred prescription.
2. Provide all information required to be on a prescription:
3. Date of issuance of original prescription;
4. Original number of refills authorized on original prescription;
5. Date of original dispensing;
6. Number of valid refills remaining and date(s) and locations of previous refill(s);
7. Pharmacy's name, address, DEA registration number and prescription number from which the prescription information was transferred;
8. Name of pharmacist who transferred the prescription.
9. Pharmacy's name, address, DEA registration number and prescription number from which the prescription was originally filled;

1. Dispensing is made only by a pharmacist
2. Prescription not required by federal law
3. Note limits (See Sec 1306.26) that may be dispensed at retail to the same purchaser in any given 48-hour period;
4. Requirements for dispensing

1. The purchaser is at least 18 years of age;
2. The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish suitable identification (including proof of age where appropriate);
3. A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist. The book shall contain

1. the name and address of the purchaser,
2. the name and quantity of
3. controlled substance purchased,
4. the date of each purchase, and
5. the name or initials of the pharmacist);

Individual practitioners may not issue prescriptions for a narcotic drug for the purpose of detoxifying or maintenance treatment of an addict. Individual practitioners who wish to treat these kinds of cases must obtain separate registration as a narcotic treatment program. This involves different reporting and security requirements.

Out of Class assignment

Out of Class assignment

What is professional liability insurance?

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

1.Identical amounts of the identical active ingredient in the identical dosage form

2.same compendial standards, same disolution rates

3.cannnot have proven bioequivalence problems in Orange Book

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

5.Continuing law authorizes a pharmacist to fill a prescription with a generically equivalent drug, unless otherwise instructed by the purchaser or prescribing practitioner. Under prior law, the pharmacist could not select a generic drug unless the price was less than the price of the brand name drug prescribed. The act permits a pharmacist to select a generic drug if the price is less than or equal to the brand name price.

6.The bill repeals a provision that requires the pharmacist to provide verbal notification to the purchaser that a generic substitution has been made, but maintains the generic substitution labeling requirement.
The bill also repeals a provision that expressly requires a pharmacist to pass on the cost difference to the purchaser.

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

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. Page 219

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

When pharmacists may dispense controlled substances

When prescribers may prescribe controlled substances

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.

The records required by divisions (b)(1) and (4) of this section shall contain the following:

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

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 with respect to labeling and packaging of the controlled substance

Sec. 3719.121
License to be suspended if addiction occurs

Sec. 3719.172 Hypodermics
Not to be displayed

Sec. 3719.44
Board’s authority to modify CS schedules

1. Add
2. Transfer
3. Remove

Sec. 3719.81 Illegal use of drug samples
Samples OK if:

1. Directly to patients
2. Original container
3. Stored under proper conditions
4. Expiration date
5. Keep away from unauthorized persons
6. OTC drugs exempted

Ordering of controlled substances by Emergency Medical Services

For schedule II substances must use form 222

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

This set of code sections deals with the practice of pharmacy in Ohio

(B) Practice pharmacy

1. Managing drug therapy.
2. Dispensing and compounding drugs.
3. Dispensing devices.
4. Counseling patients.
5. Reviews of drug regimens.
6. Reviews of drug utilization.
7. Drug therapy advice.
8. Consult Agreement

(C) Compounding

(D) "Consult agreement" means an agreement to manage an individual's drug therapy that has been entered into by a pharmacist and a physician.

(F)"Dangerous drugs"

(H) "Prescription" means A written, electronic, or oral order for drugs or combinations or mixtures of drugs to be used by a particular individual or for treating a particular animal, issued by a licensed health professional authorized to prescribe drugs.

(I) "Licensed health professional authorized to prescribe drugs" or "prescriber"
(1) A dentist
(2) An advanced practice nurse
(3) An optometrist
(4) A physician authorized under chapter 4731. of the revised code to practice medicine and surgery, osteopathic medicine and surgery, or podiatry;
(5) A veterinarian

(N) Price Information

(O) Wholesaler, manufacturer, and terminal distributer of dangerous drugs

1. 18 years old
2. Good moral character and habits
3. Pharmacy degree
4. Completed internship requirements

1. Current certificate to practice and must have been registered by exam in other state
2. Good moral character
3. Similar credentials at time of registration
4. Oher state must reciprocate with Ohio. Ohio does not reciprocate with Cal & Fla

1. Renewed every year by September 15
2. Must carry ID card with you at all times when practicing and certificate must be displayed at principal place of employment
3. Lapsed for>60 days but <3 years - only have to pay fee to renew
4. 4729.13 Renewal of Identification card after 3 year lapse

Must take exam again

Note - If registered and practicing in another state only needs to pay fee

1. Notice and opportunity for hearing
2. Grounds spelled out Section (A)
3. Board can take action even if no court action taken

Section 4729.281 Pharmacist dispensing drug without a prescription; Conditions
Under the act, a pharmacist may dispense or sell a dangerous drug, other than a Schedule II controlled substance, without a written or oral prescription from a licensed health professional authorized to prescribe drugs if all of the following conditions are met:

1. Rx on file but no refill
2. R.Ph. Unable to obtain authorization for refill
3. (a) essential to patient’s therapy and

(b) failure to dispense would result in harm to patient

4. 72 hour supply
5. Maintain record and notify prescriber

Section 4729.29 Prescriber dispensing and labeling
When a prescriber personally furnishes drugs to a patient pursuant to division (a)(1) of this section, the prescriber shall ensure that the drugs are labeled and packaged in accordance with state and federal drug laws and any rules and regulations adopted pursuant to those laws. records of purchase and disposition of all drugs personally furnished to patients shall be maintained by the prescriber in accordance with state and federal drug statutes and any rules adopted pursuant to those statutes.

1. Definition of "Generically equivalent drug" See section 3715.01(16)
2. Prescriber must WRITE D.A.W. or Dispense as Written to avoid substitution
3. Inform purchaser of price difference and right to refuse the drug selected
4. Labeling requirements Section (B). Notify of generic substitution

Section 4729.39 Consult agreements authorized; conditions
"Consult agreements" between pharmacist and physician

1. Agreement between R.Ph. and physician
2. - Separate agreement for each patient
3. - May include monitoring and modifying a prescription
4. - Must be signed by physician, R.Ph. And patient-
5. R.Ph. To maintain records
6. - Prior to taking action R.Ph. must attempt to contact physician and must must contact physician within 48 hrs
7. - Any one of the parties may terminate the agreement
8. - Boards to adopt rules

Ohio’s Dangerous Drug Distribution Act
This set of code sections deals with the selling and distribution of dangerous drugs between manufacturer, wholesaler, terminal distributor, and practitioner

(1) "Category I" means single-dose injections of intravenous fluids, including saline, Ringer's lactate, five per cent dextrose and distilled water, and other intravenous fluids or parenteral solutions included in this category by rule of the board of pharmacy, that have a volume of one hundred milliliters or more and that contain no added substances, or single-dose injections of epinephrine to be administered pursuant to sections 4765.38 and 4765.39 of the Revised Code.

(2) "Category II" means any dangerous drug that is not included in category I or III.

(3) "Category III" means any controlled substance that is contained in schedule I, II, III, IV, or V.

4729.60 Certificate required by wholesalers
Wholesaler must obtain certificate of licensure from terminal distributor before selling DD

Terminal distributor must obtain wholesaler’s certificate number before purchasing DD

Pharmacy Practice-Internship (Chapter 4729-3)
Pharmacy Practice - Administration (Chapter 4729-05)
Pharmacy Practice—Impaired Pharmacists (Chapter 4729-6)
Board Regulations (Continued)
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)

(A) "Pharmacy internship"

(B) "Supervised practical experience"

(C) "Internship site"

(D) "Preceptor"

(F) "In good standing"

(G) "Statement of Preceptor"

(H) "Practical experience affidavit"

4729-3-02 Registration as a pharmacy intern
Intent of registration
Qualifications

4729-3-05 Internship credit
No credit before registration
Statement of preceptor form
Submit PEA’s by March 1 of following year

(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

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 responsible person.
-Cannot be responsible pharmacist for more than 1 location
- Need board approval for more than 1 location
- Change in responsible pharmacist to be reported within thirty days

4729-5-13 Prescription Format
-Must comply with 4729-5-30
-Preprinted forms are permitted if
- no controlled substances
-one prescription per form

Format for controlled substance prescriptions
-4729-5-30
-One prescription per form
-Quantity written both numerically and alphabetically
-If preprinted, only one drug and strength per form
-Remember rule for residents and staff physicians

See preprinted prescription examples in supplement.

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 number
Name or initials of pharmacist
Trade name or generic name and name of distributor
Quantity dispensed
Special rules for small containers

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

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

Before dispensing, RPh shall review patient profile for items listed

If any problems encountered RPh to take appropriate action

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

Pharmacist or intern must counsel patient

See items listed page 138

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
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
Prescription copies may be transferred by fax machine. Keep in mind positive identification requirements of transferring and receiving pharmacists.

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

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

Long, technical regulation

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.

If written for generic, either brand name or generic name and distributor must be recorded on face of prescription.

Note section D. Patient not to receive more drug than intended

Note section (E)(4) If larger quantity dispensed. MD approval must be obtained

4729-5-27 Recordkeeping (More)

Be aware of all of division (E) requirements

Keep for three years

Longest regulation

Immediate retrieval of last twelve months prescriptions

Three day retrieval of prescriptions from previous 36 months

Three ways of keeping refills records

Initial and date back of original Rx

Computer generated printout signed by all pharmacists

Tamper evident log

Various printouts may be required

Know procedure for down time

Purged records must be maintained for 36 months

System must produce audit trail

Rx records are not public record

Cannot be released to anyone except those listed in this regulation

Records may be released to authorized law enforcement officials. They must provide receipt.

Most important rule for retail pharmacists.

Rx must be for legitimate medical purpose

Dated and signed on date issued

Must there full name and address of patient and prescriber.

Written prescriptions must be signed

Prescriptions may be transmitted orally or by fax. However sender must identify themselves

Rx must have specific number of refills specified or period of time.PRN refills are not permitted.

First dispensing must occur within six months.

Rx for dangerous drugs and Schedule V drugs are valid for one year

Schedule III and IV drugs are valid for six months or five refills

Refills only as authorized

No coded prescriptions are allowed

Agents of practitioners must identify themselves with their full names

Pharmacy must receive original copy

Automated paperless systems must be approved by pharmacy board.

See Ohio State Pharmacy Board Compliance Bulletin 98-001 and Medical Board Rule 4731-11-04 in supplement.

Must store 75 on NAPLEX exam and 75 on jurisprudence exam

If license lapsed for three years must meet above requirements.

Must receive prior approval from pharmacy board.

Must maintain on going quality assurance programs

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. 4.5 CEU’s (45 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 in other state can transfer to Ohio

4729-7-03 Evidence of CPE Experiences
Keep certificates

4729-9-01 Definitions
(A) Dangerous drug
(B) Adulterated - drug is adulterated if beyond expiration date.
Revoke, suspend, 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 on page 162
- 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. Division (C) Page 163

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

4729-9-10 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 this regulation with Federal 5% C.S. regulation for distributors.

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 (a)-(g)
-Note (3) top of page 165
-And Note also (C) page 165

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 theft or significant loss of any dangerous drug CS.
Notify board immediately by telephone
Theft CS use form 106
Form 106 to be filed with board within thirty days
Must also report 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.

4729-9-18 Licenses to be readily available

4729-9-20 Repackaged drugs
- 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)

4729-9-21Drugs 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

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

4729-17-01 Definitions:Institutional Facilities
(A) Institutional Facility
(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 page 192
(D) Records of distribution of drugs
-Note Items 1-5
-Item 5 Positive ID of person receiving drug if controlled substance
-Records of administration to contain items (a)-(e)

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

2. Drug orders to contain
   Name of patient
   Name, strength & dosage form of drug
   Directions & route if not oral
   Date prescribed
   Prescriber’s positive ID
3. Outpatient orders. Same rules as retail prescriptions.
4. 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

(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.
4729-29-02 PHARMACIST AS AGENT.
4729-29-03 RECORDS
4729-29-04 THERAPY MANAGEMENT BY FORMULARY
4729-29-05 SIGNATURES REQUIRED ON A CONSULT AGREEMENT

NOTIFICATION OF THE INTENDED ACTION

PROVIDES THE PHYSICIAN WITH THE OPPORTUNITY TO RESPOND IN A TIMELY MANNER

MAY INCLUDE, BUT IS NOT LIMITED TO
(A) PERSONALLY MEETING
(B) TELEPHONE DISCUSSION
(C) FACSIMILE IN A MANNER THAT CONFIRMS DELIVERY;
(D) ELECTRONIC MAIL THAT CONFIRMS DELIVERY;
(E) ANY OTHER METHOD IN WRITING
(F) ANY OTHER METHOD OF NOTIFICATION AS OUTLINED IN THE CONSULT AGREEMENT

1. FOR THE PURPOSE OF IMPLEMENTING ANY ACTIONS INITIATED AS A RESULT OF A CONSULT AGREEMENT
2. CONSULTING PHARMACIST IS NOT THE DISPENSING PHARMACIST OR THE PERSON ADMINISTERING THE DOSAGE ORDERED
3. THE CONSULTING PHARMACIST SHALL BE DEEMED TO BE ACTING AS THE
4. AGENT OF THE CONSULTING PHYSICIAN

Must be in writing

1. ALL CONSULT AGREEMENTS AND RECORDS OF ACTIONS TAKEN
2. MAINTAIN THESE RECORDS FOR AT LEAST THREE YEARS FROM THE DATE OF THE LAST ACTION TAKEN
3. CONSULT AGREEMENTS SHALL BE CONSIDERED CONFIDENTIAL PATIENT RECORDS

CONSULT AGREEMENT PROVISIONS DO NOT APPLY WITHIN AN INSTITUTIONAL

FACILITY WHEN THE PHARMACISTS ARE FOLLOWING THE REQUIREMENTS OF A FORMULARY SYSTEM

A CONSULT AGREEMENT MUST BEAR THE SIGNATURES OF

1. ONE PATIENT OR CAREGIVER,
2. ONE PHYSICIAN, AND
3. ONE PHARMACIST.

THE CONSULT AGREEMENT MUST DEFINE THE DIAGNOSIS OR DIAGNOSES
WHERE THERE IS A GROUP OF PHYSICIANS OR PHARMACISTS WHO MAY BE CARING FOR THE PATIENT,

1. THE CONSULT AGREEMENT SHALL BE SIGNED BY THE PRIMARY PHYSICIAN AND THE PRIMARY PHARMACIST.
2. MAXIMUM OF FOUR, WHO MAY BE COVERING FOR THE PRIMARY PHARMACIST.