Drug Regulation &
Control
Chapter 3
Drug Regulation & Control
LEARNING OBJECTIVES
 Understanding the importance and role of regulation.
 Knowledge of the history of drug regulation.
 Understanding of the drug development and approval
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process.
Knowledge of label and labeling requirements.
Knowledge of control substance schedule and
requirements for handling cs.
Understanding of recall process.
Understanding of liability.
Timeline
The safety and effectiveness of food, drugs, medical devices is
regulated by legal systems.
 1906 Food & Drug Act : Government pre-approval of drugs is
required.
 1914 Harrison Tax Act : Prescribing of narcotics with a license
only.
 1927 Food, Drug and Insecticide Administration (FDA) is
formed
 1938 Food, Drug and Cosmetic Act: Replaces 1906 Act after
poisoning of 107 people; started new system of drug
regulation.
Timeline continued
 1950 Alberty Food Products v. U.S. : Requires indications on a label.
 1951 Durham-Humphrey Amendment: Establishes what drugs are
considered prescription(Caution: Federal Law prohibits dispensing
without a prescription)
 1962 Kefauver-Harris Amendment : Requires proof of safety before
marketing (Thalidomide) and disclosure of accurate information
about side effects.
 1966 Fair Packaging and Labeling Act : Requires honest and
informative labeling on drugs (product id, name and place of
business of mfr, packer or distributor and net qty of contents).
 1970 Poison Prevention Packaging Act : Child-proof packaging.
 1970 Controlled Substances Act: Regulates drug abuse.
Timeline continued
 1983 Orphan Drug Act: Research for rare diseases.
 1984 Drug Price Competition and Patent Term Restoration Act
(Hatch-Waxman) : Quicker introduction of lower cost generic
drugs
 1987 Prescription Drug Marketing Act : Licensed wholesalers,
reduced health risks.
 1990 Omnibus Budget Reconciliation Act: Required counseling of
Medicaid patients.
 1996 Health Insurance Portability and Accountability Act: Patient
confidentiality.
New Drug Approval
All new drugs require FDA approval before they can be
marketed in the United States.
The drug must be safe and effective.
Center for Drug Evaluation and Research (CDER)
Testing process – 8.5 years
Laboratory
animal
humans
Clinical trials
New Drug Approval
Clinical Trials
 Phase I: 20-100 healthy volunteers; months; (mainly safety)
 Phase II: hundreds of volunteers; up to 2 years; (short-term
safety but mainly effectiveness)
 Phase III: up to thousands of volunteers; 1-4 years; (safety,
dosage and effectiveness)
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Discovery: 2 to 10 years
FDA review/approval
Post-marketing testing
Approved by FDA: 17 years
Five year extension on patent
(Hatch-Waxman Act of 1984)
Marketed Drugs
Drug patents provide an exclusive right to market for specific
periods of time (20 years). Once the patent is expired, other
manufactures may copy the drug and release it under the generic
name (must be pharmaceutically and therapeutically equivalent).
Pharmaceutically equivalent – contain the same amount of drug in
the same dosage form.
Therapeutically equivalent – when administered to the same
individual, in the same dosage regimen, it will provide the same
therapeutic response.
Marketed Drugs
 Once approved by the FDA, a new brand drug is
entered into the market. When all of the money for the
research and development is paid back, a generic drug
will be marketed by other companies.
 Generic drugs are required to be identical to the
brand-name product listed in the orange book (FDA’s
Approved Drugs Products publication) in
terms of active ingredient and dosage form as well as
route of administration and strength.
National Drug Code
(NDC Number)
 The National Drug Code System was originally established by
Medicare as part of an outpatient drug reimbursement program
and was used as a method to identify drugs during commercial
distribution.
 Comes in two formats, a 5-3-2 format and a 5-4-1 format. Each
manufacturer/packager selects which format they wish to follow
and uses that format for its products
National Drug Code
(NDC Number)
EXAMPLE: 01234-5678-45
 1st set (five digits): manufacturer
 2nd set (four digits): drug info (i.e. medication strength and
dosage form)
 3rd set (two digits): package size
OTC Labeling Requirements
 Product name
 Name and address of manufacturer or distributor
 List of all active and other ingredients
 Amount of contents
 Adequate warnings
 Adequate directions for use
Text p. 39
FDA Proposed OTC label
Prescription Drug Label
Name and address of dispenser
 Prescription serial number
 Date of RX filling
 Expiration date
 Prescriber name
 Patient name
 Directions for use
 Cautionary statements
Text p. 43
Controlled Substances
Regulations
 Labels (classifications)
 Record keeping (inventory, Sch II are kept separately)
 Security (Sch. II in the locked cabinet)
 Joint responsibility (prescriber and pharmacist)
 DEA number (must be used for controlled drugs Rxs)
 DEA form 222 to order C I and C II drugs. (p.45)
DEA Form
Used to order controlled substance I and II
Must be signed by a registered person.
Three copies:
Green copy is sent to the DEA.
Brown copy is kept for your records.
Blue copy is kept by the company issuing the form.
Must be kept in a separate file from other invoices.
DEA Form 222
Prescription Fraud
Scrutinize prescriptions:
 Do quantities, directions, or dosage differ from usual
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medical usage or practice?
Are the directions written in full with no abbreviations?
Is it a photocopy?
What is the date on the prescription?
Does the prescription look as though it has been wet?
Prescription Fraud
Types of fraudulent prescriptions:
 Stolen prescription pads
 Quantities altered for larger amounts
 Telephone number for verification changed on
prescription pad
 Uses computer to duplicate pads
 Uses acetone to remove ink and rewrites
 Called in by patient or other unauthorized personnel
Prescription Fraud
Patterns of possible diversion:
 Prescriber writes unexpectedly large quantities
 Diverter returns too frequently for refills
 Presents prescriptions for multiple drugs with
abuse and written in names of other people
 Does not use insurance cards
 Pays cash
Prescription Fraud
Preventing Diversion:
 Encourage physicians to use tamper-resistant
prescription pads
 Suggest to physicians to write the quantity and
strength in both numbers and letters
 Know the prescriber, signature, and DEA#
 Request proper identification if in doubt
 If you believe forgery, do not dispense; call your
local or state police
DEA Numbers
Assigned to prescribers for dispensing controlled drugs.
Ex: AR4342793
 add 1st +3rd +5th number = X
 add 2nd+4th +6th number = Y
 multiply by 2 = Z
 then add X+Z =__ __
 The total should be a number whose last digit is the
same as the last digit of the DEA number.
 (4+4+7=15 3+2+9=14 14x2=28 then 15+28=43)
Exempt narcotics
Are medications that contain habit-forming
ingredients but can be sold without a Rx
Only the pharmacist can dispense
Limited dosage units
Purchasers are at least 18 years old
Transactions are documented in a record book
to track who/what/how much/when
Recalls
 Reports of adverse effects
 Manufacturing problems
Class I: serious adverse effects or death
Class II: cause temporary but reversible effects
Class III: not likely to cause adverse effects
Recalls
1. Report adverse effect to the FDA.
2. FDA will contact the manufacturer.
3. Manufacture contacts wholesalers, retailers,
and all consumer levels.
4. Personal phone calls are made or letters are
sent to customers.
5. Recalls are listed publicly.
6. Listed in the weekly FDA enforcement report.
Investigational Drugs
 Investigational drugs are in the final stages for
approval from the FDA.
 Used in patients with a life-threatening disease
before marketing.
 When the drug is expired, the product is returned
to the sponsor (for example, the prescriber).
Emergency Contraceptives
 Dual marketing status – both Rx (17 years and
under) and OTC status
 In Texas the pharmacist is not eligible to
prescribe Plan B to the patient under 17.
PHARMACY LAWS
Federal and State Laws
Federal Laws
A prescription for a controlled substance must meet the
following requirements:
 Patient’s full name and address
 Practitioner’s name, address, and DEA#
 Drug name, strength, dosage form, quantity, directions, and
refills
 Must be written in ink or typewritten and signed by
prescriber
 Controlled substance must be dated on the date of issuance
Federal Laws
Schedule III, IV, and V prescriptions:
 May be verbal, written, or faxed and may be refilled if
authorized by the prescriber
 Schedule III and IV may be refilled up to five times
within six months
 Schedule V may be refilled as directed by the prescriber
 Schedule II requires a written prescription by the
prescriber that is signed and may not be refilled
Federal Laws
 Record keeping:
 C-II need to be ordered on DEA form 222
 C-II hard copies needs to filed separately from all
other hard-copy prescriptions
 All hard-copy prescriptions need to be kept for two
years from the date of the last refill
 Security for controlled substances: locked cabinet,
dispersed, other secure storage
 Theft or loss: Report immediately and file DEA form
106d
State Laws
 Each state enacts laws governing the manufacturer,
distribution, prescription, and dispensing of controlled
substances; pharmacists must comply with both federal
regulations and regulations in the state(s) in which they
practice.
 Such regulations may reside in different departments of
the state, such as the board of pharmacy, the
department of health, or consumer affairs.
Law and the Technician
Liability (can be prosecuted for misconduct)
Negligence – failing to do what you should have done:
 Incorrectly labeling the Rx;
 Failing to maintain patient confidentiality;
 Failing to recognize expired drugs;
 Calculation errors;
 Dispensing the wrong medication;
 Incorrect handling of controlled substance;
 Inaccurate record keeping.
Regulating Authorities
 American Society of Health-System Pharmacists,
 United States Pharmacopeia – sets standards for the
manufacture and distribution of drugs and related
products in US.
 Joint Commission on Accreditation of Health Care
Organizations – establishes standards and monitors
compliance for health care programs in US.
 The American Society for Consultant Pharmacists – sets
standards for practice for pharmacists.