Pharmacy Law
January 19, 2011
Federal Food, Drug, and
Cosmetic Act
(a statute)
21 USC §301 et seq.
Pure Food & Drug Act of
First time food and drug regulation
considered in US
Established FDA
Goal: protect health and safety
associated with unsanitary and poorly
labeled food and drugs
– Dealt with adulterated and misbranded
food and drugs in interstate commerce
Food, Drug and Cosmetic
Act of 1938
Expanded 1906 law
Result of deadly consequences of diethylene
glycol (antifreeze) in anti-infective preparation
Required drugs to be safe as labeled
Label must contain adequate instructions for
use and warnings
Later amendments provided for batch
uniformity of penicillin and insulin
Amendment of 1951
Established prescription and OTC classes of
Established the federal caution required on all
prescription drug products
– “Caution: Federal law prohibits dispensing without
a prescription”
Establishes requirements for oral
Establishes requirements for prescription
Kefauver-Harris Amendment
Resulted from thalidomide disaster in Europe
– FDA did not approve the new drug application for
product in US
Added safety to requirements for marketing
and sales of drugs
Gave FDA control of prescription drug
marketing and advertising
Established good manufacturing practices
Required more research requirements and
reporting of adverse drug events
Prescription Drug Marketing
Act of 1987
Restricts pharmacies from receiving or
distributing drug samples from manufacturers
Prohibits sale of drug samples by hospitals or
other health care entities
Establishes state licensure requirements for
pharmaceutical wholesalers
FDA Modernization Act of
Streamlined FDA drug approval process to
allow expedited availability of drugs and
Expands manufacturers’ ability to
communicate information regarding off-label
Required FDA to establish public standards
regarding approval process and a mission
FDA Modernization Act of
Established a fast-track approval process for
drugs used for life-threatening diseases
Established a databank with clinical trial
Authorized review of clinical investigations
Gives FDA full authority to establish labeling
requirements for OTC agents
Other Important FDA
Orphan Drug Act of 1983: expanded access
to drugs for rare diseases
Drug Price Competition and Patent Term
Restoration Act of 1984: streamlined
requirements for bringing generics to market
Prescription Drug User Fee Act of 1992:
requires manufacturers to pay fees to FDA for
drug approval process
Food and Drug Administration Amendments
Update of 2007 (FDAAA): provisions
designed to improve access to consumer
drug info and adverse event reporting
Focus of FDA Today and in
the Future
Appropriate prescription written prescription
information for consumers and enhancements in
Approval of “follow-on” biologic agents
Drug importation
Enhanced safety in clinical trials
Comparative effectiveness of certain medications
compared to others
– Joint efforts with other agencies
Expansion of FDA’s role
2009 law now expands FDA oversight to
tobacco and tobacco products
– Currently, tobacco NOT regulated by FDA
– New law would regulate tobacco in a
manner similar to medications
Global expansion with FDA-registered entities
in foreign countries primarily China, India,
and Canada
– Inspections of foreign facilities?
– FDA already has presence in South
Food versus Drug
FDA Definition of Drug
Recognized by official compendia in the US
– USP, official Homeopathic Pharmacopoeia of US,
National Formulary, or any supplement to any of
Used for the diagnosis, cure, mitigation,
treatment or prevention of disease in man or
other animal
 Intended to affect the structure or any
function of the body of man or other animals
VAC substantially adopts FDA definition
Food v Drug
Food is not intended to affect the structure of the
human body and is not intended to be used for
disease states
Drugs have stringent and long clinical testing
requirements before marketing
– Foods found to be drugs can be removed from market
– Dietary supplements not considered drugs
Suppliers must be careful when they make claims
regarding products because can result in products
classified as drugs by FDA
– Courts will consider advertising claims made by
manufacturer to determine whether a drug is marketed as
food or drug
– Courts also consider label and labeling of product
– Often conclusions are subjective based on evidence
Dietary Supplements
Vitamins, minerals, herbs or other botanicals, amino
acids, concentrate, metabolite, extract
Governed by the Dietary Supplement Health and
Education Act of 1994 (DSHEA)
– FDA permits certain health claims so long as
certain scientific agreement exists for claim
• Vitamins in orange juice determined by
American Heart Association to help prevent
heart disease
• If the claims indicated that vitamins definitely
prevent heart disease, then potentially drug
Pharmacists may recommend certain dietary
supplements based on scientific and clinical
information about the product
Marketing dietary supplements
Over the past several years FDA reviewed claims by
certain food manufacturers and sent warning letters
regarding claims
Cheerios slogan: “Give us 6 weeks, we will lower
your cholesterol”
– FDA letter warned General Mills that its
advertisement is a therapeutic claim and therefore
the product is a drug subject to a new drug
Marketing of Activia by Dannon
– Federal Trade Commission (FTC) action
Marketing dietary supplements
Appropriate claims for a dietary supplement include
– Structure/function claims acceptable
– May help
– At least two clinical research studies have shown
that product may assist in the medical claim being
– Definitive statements generally considered the
realm of a drug product
Foods and Dietary Supplements
Payment System Implications
Generally, health plans do not provide
reimbursement for dietary supplements such as
vitamins and minerals
– Limited exceptions include Vitamin B12 and Nicacin
Some payers, including state Medicaid programs, will
pay for enteral food supplements such as Ensure that
help to prevent wasting and cachexia
Medicare Part D program excludes payment for
dietary supplements and for enteral food
Adverse Event Reporting for Dietary
Supplements and OTCs
FDAAA includes provisions to report adverse drug events
associated with dietary supplements and OTC medications by
requiring reporting of serious adverse effects associated with
the product
Life-threatening experience
In-patient hospitalization
Persistent or significant disability or incapacity
Congential anomaly or birth defect
Requires medical or surgical intervention to prevent one of the
outcomes described above
Responsibility is the distributor, packer or manufacturer that
appears on the label
– Retailers including pharmacies do not have to report directly but
must communicate incidences to the proper entity
Information must be submitted to FDA within 15 days of event
and new medical developments reported within the first year of
Label and Labeling
Definition: Label
Written, printed, or graphic matter upon the
immediate container of any article
– Includes container or wrapper
VAC substantially adopts FDA definition
under § 54.1-3401. Definitions
Definition: Labeling
Definition includes information on label and all other
written, printed, or graphic matter upon any article or
any of its containers or wrappers
 Much broader than label and many more implications
 Information not sent directly with the drug may be
considered labeling if part of the integrated
distribution process
 Includes OTC and Rx labeling
VAC substantially adopts FDA definition under §
54.1-3401. Definitions
Rx v. OTC Labeling
Basic information same with some differences
– Rx must contain the “Federal Caution”
– OTC must contain very specific information related
to warnings to stop use
– OTC must contain specific information regarding
the dosages and the patient population intended
• Rx provides information related to the
recommended and usual dosage
– OTC must contain specific information regarding
the route of administration, appropriate time of
administration, etc
– Rx contains information for type of container used
to dispense
Professional Package Insert
Included in the labeling of the prescription drug
Must accompany the drug product and provide
essential scientific and medical information needed
for the safe and effective use of the drug by health
care professionals
Rules implemented June 2006 streamline information
in professional package insert and must be fully
implemented for all by 2013
Attempts to remove much of the legal jargon in
package insert and highlights the most important
information up front including boxed warnings
Boxed warnings
FDA approved warnings required for products with certain
contraindications or serious warnings, particularly those
that may lead to death or serious injury
– Information appears in a text box in the package insert
• Contains warnings or contraindications, special or
restricted uses, risk mitigation strategies, testing or
other special requirements for use of the product
– Information about common off-label uses with
unacceptable risk
• For example: antipsychotics for dementia in
– Products approved with black box warnings may or
may not require consumer-focused warnings, such as
Patient Package Insert
FDA law requires leaflets to be included with certain
medications, including products containing estrogens,
DES, oral contraceptives and intrauterine
contraceptive devices
Manufacturer must notify pharmacist to insert leaflet
in each prescription dispensed
Must provide general information regarding the risks
associated with use and potential adverse effects,
and pulmonary embolism
Applies in both community pharmacy and institutional
settings (modified form)
– In institutions can be provided upon administration
of first dose and then once every thirty days
Medication Guides
Required for certain products posing a “serious
and significant concern” other than estrogencontaining products if FDA finds
– Patient labeling could help prevent serious adverse effects
– Product has serious risks that patient could benefit from
– Patient adherence crucial to effectiveness of drugs
MedGuide must be approved by FDA
Must be in English
– Any document not in English that purports to be a
MedGuide has not been FDA approved
Medication Guides
Manufacturer not required to provide MedGuide leaflet
with products but must
– Provide information in professional package insert
regarding the requirement to provide MedGuide with
approved products and
– Must provide pharmacies with a mechanism to
obtain MedGuides through a website, distribution
center, etc.
MedGuide required for Accutane, Lariam, all
antidepressants and others
– Complete list:
MedGuides v Pharmacy generated
consumer medication information
Pharmacies may also provide consumer
medication information from its computer
systems or other source of information
– Pharmacy-generated consumer medication
information not FDA approved and currently does
not have to be in a standard format
– Pharmacies that provide its own information must
also conform to FDA required consumer medication
information requirements
Misbranded Drugs
FDA definition
VAC §54.1-3462
Considers whether the label or labeling
of a drug is false or misleading
FDA must approve information
Misbranded Drugs: Key Points
Label or labeling must not be false or misleading
Package must contain information on manufacturer,
packer, or distributor
Must contain all statements, words or designs required or
approved by FDA, including package inserts, MedGuides,
Controlled substances must contain “Warning-May be
Habit Forming”
Prescription drugs must have established name or
ingredient prominently displayed
– Proprietary name must be included in type 1/2 the size
of established name
– VA Board of Pharmacy may grant exceptions
Misbranded Drugs: Key Points
Information regarding dosages that might be
dangerous to health or unsafe
Information related to dangers of use in
Special packaging requirements to prevent
deterioration, etc.
If it fails to meet conditions of the Poison
Prevention Packaging Act
Adulterated Drugs
See FDA definition
VCA definition §54.1-3461
Adulterated Drugs
Includes drugs that consist in whole or in part of filthy,
putrid, or decomposed substances
Drugs prepared, packed or held in unsanitary
Drugs prepared, packaged, processed or held under
conditions that violate GMPs
Drugs that purport to be those recognized in official
compendia but quality or purity falls below the
Drugs mixed or packed to reduce quality or strength
Adulterated Drugs
Applies to preparation conditions for the
drugs, not the drug itself
Mostly applies to manufacturers but can
apply to pharmacies if
– A pharmacy receives an adulterated drug and
then sells the drug
– A pharmacy compounds medications under
conditions that result in adulteration
• State implications different from federal law
Current Good Manufacturing
Practices (CGMPs)
FDA regulations that establish minimal requirements
for the methods, facilities, or controls used in the
manufacture, processing, packaging, or holding of a
drug product
Ensures product meets FDA quality and purity
Only apply to manufacturers except if a pharmacy
engages in activities deemed manufacturing
Manufacturer Compliance with
CGMPs and FDA Registration
Manufacturers required to register with FDA
– Pharmacies NOT required to register with FDA
but in some cases could be inspected
Manufacturer registration with FDA valid for two
years and FDA will inspect one time within the two
year period
Purpose of inspections
– Production and control procedures to ensure
proper identity, strength, quality, and purity of
– Identify deficiencies and provide follow-up for
Manufacturer could be required to recall drugs from
market or FDA could seize all adulterated drugs
Product Tampering
Violations associated with intentional product
tampering the joint authority of FBI, Department of
Agriculture, and FDA
FDA rules require some OTC products to be in
tamper-resistant packaging
– Must ensure that packaging provides visible
evidence that tampering has occurred
FDA Drug Approval Process
New Drug Approval Process
Applicant must provide
– Reports of drug safety and efficacy
– Drug components and composition
– Methods, facilities, and controls used in
manufacturing, processing, and packaging
– Samples of drugs
– Proposed labeling
Definition: New Drug
Drug not generally recognized by qualified
experts as safe and effective for use under
the conditions recommended in the labeling
– Generally recognized as safe (GRAS)
– Generally recognized as effective (GRAE)
Must be used for a “material” amount of time
for indications in the labeling
FDA determination on new drugs considered
final authority; not court decision
Sometimes applies to new drugs for different
indications, forms, etc
§201(p) FDCA
New Drug Application
Investigational new drug application
– Drug name, composition, manufacture and quality control
data, preclinical animal investigations regarding
pharmacological, pharmacokinetic, and toxicological
– Approval if IND within 30 days, then drug moves to clinical
Clinical trials in humans
– Phase I: examines adverse effects in small studies, toxicity,
metabolism, bioavailability, elimination and other
pharmacological effects
– Phase 2: tested for efficacy on patients with the
– Phase 3: large clinical trials for safety and efficacy
– Phase 4: post-marketing surveillance
IND for Treatment
Used for individuals with serious or life-threatening
injuries meeting following requirements
Serious or immediate life-threatening disease or condition
No comparable or satisfactory alternative
Drug is under investigation for treatment of condition
Sponsor seeking marketing approval
Sufficient evidence of safety and effectiveness for serious
– Reasonable basis to conclude the drug may be effective and
would not expose individuals with immediate life-threatening
diseases to unreasonable and significant risk
FDA MedWatch Program
Voluntary system for healthcare professionals to
report ADRs to FDA
Information can be found at
Voluntary and confidential
Move to make process more transparent, required?
FDA Risk Evaluation & Mitigation
Strategies (REMS)
Another form of surveillance implemented by FDA in 2008
to establish formal protocols to communicate information
about safety and efficacy concerns with certain medications
– Many medications already approved for REMS have
– REMS developed by manufacturers and approved by
– A list of currently approved REMS available at
– More REMS expected in the future
REMS components
REMS include at least one of the following elements
designed to ensure safety of use
– Practitioners must be certified or have training to prescribe
– Pharmacies and other dispensers or those who administer must
have special certification
– Drug distribution is limited to only certain settings such as clinics
or hospitals
– Patients who receive the medication must receive special
information regarding safe use, including required lab testing
– Patients must be monitored when using the medication
– Patients must be enrolled in a registry to use drug
Manufacturers that fail to comply with REMS
requirements subject to fines and penalties, including
misbranding of products
REMS components
Review “Fictitious Drug REMS” beginning on page 30 of
the following document to understand components of
FDA Drug Safety Website
Provides comprehensive information on
postmarketing surveillance for consumers
and professionals
For Next Week
Review definition of OTC drug under FD&CA
Review compounding provisions under FD&CA and
general info on FDA website
Review FDA generic equivalency information
Skim DEA regulations
Section 1300.01; 1301; 1306
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