Chapter 2
Pharmacy Law,
Regulations,
and Standards
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1
The Need for Drug Control
• Laws in the US are generally stricter than in
other countries.
• Many organizations exercise control:
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Courts
Federal and state legislatures
Federal and state agencies
US Pharmacopeia
Professional organizations
Individual institutions (hospitals, pharmacies, etc.)
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History of US Statutory
Pharmacy Law
• During the 1800s, drugs in the US
were unregulated.
• Opium was widely available without a
prescription.
• Traveling medicine shows proclaimed
the latest “miracle cure.”
• There were major concerns regarding
the purity of imported drugs.
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Pure Food and Drug Act of 1906
• Passed to fight abuses in drug
formulation, labeling, and marketing
• Forbade drug labels from containing
false information
• Proved to be unenforceable
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Food, Drug, and Cosmetic
Act of 1938
• Response to manufactured drugs that were
more powerful and potentially dangerous
• Created the FDA
• Required drug makers to
– File new drug applications (NDAs)
– Prove that the product was safe for human use
– Conduct studies and submit results
• Required drugs to be safe, but not
necessarily effective
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Terms to Remember
new drug application (NDA)
the process through which drug
sponsors formally propose that the FDA
approve a new pharmaceutical for sale
and marketing in the United States
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Durham-Humphrey
Amendment of 1951
• Established distinction between
prescription and non-prescription
drugs
• Authorized verbal prescriptions
• Allowed prescription refills
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Kefauver-Harris Amendment
of 1962
• Passed in response to thalidomide-caused
birth defects
• Required drugs to be not only safe but also
effective
• Required drug makers to file investigational
new drug application (INDA)
• Lengthened time to market – balanced by
patent protection for drug makers
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Terms to Remember
Controlled Substances Act (CSA)
laws created to combat and control drug
abuse
controlled substance
a drug with potential for abuse;
organized into five schedules that
specify the way the drug must be stored,
dispensed, recorded, and inventoried
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Comprehensive Drug Abuse
Prevention and Control Act of 1970
• Referred to as the Controlled
Substances Act
• Created to combat drug abuse
• Classified drugs according to their
potential for abuse
– Schedule I: not legally dispensed
– Schedule II: no refills
– Schedule III – V: limits on refills
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Comprehensive Drug Abuse
Prevention and Control Act of 1970
CSA ranked drugs
according to their
potential for abuse
and addiction.
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Terms to Remember
child-resistant container
a medication container with a special lid
that cannot be opened by 80% of
children but can be opened by 90% of
adults; a container designed to prevent
child access in order to reduce the
number of accidental poisonings
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Poison Prevention Packaging
Act of 1970
• Passed to prevent accidental
childhood poisonings
• Applies to both prescription
and OTC drugs
• Requires child-resistant
containers that
– Cannot be opened by 80%
of children
– Can be opened by 90% of
adults
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Poison Prevention Packaging
Act of 1970
The Act
allows
some drugs
to be
dispensed
in nonchildproof
packages.
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Drug Listing Act of 1972
• Gives FDA authority to compile a list
of currently marketed drugs
• Each drug is given a unique National
Drug Code (NDC)
• Allows FDA to maintain a database of
drugs by
– Use
– Manufacturer
– Active ingredients
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Terms to Remember
orphan drug
a medication approved by the FDA to
treat rare diseases
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Orphan Drug Act of 1983
• Developing and marketing orphan
drugs is prohibitively expensive.
• Orphan Drug Act encourages their
development by
– Giving tax incentives
– Granting exclusive licenses
– Allowing expedited review and approval
• Over 250 orphan drugs have been
approved by FDA.
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Terms to Remember
brand name
the name under which the manufacturer
markets a drug; also known as the trade
name
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Terms to Remember
generic name
a common name that is given to a drug
regardless of brand name; sometimes
denotes a drug that is not protected by a
trademark; for example, acetaminophen
is the generic drug name for Tylenol
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Drug Price Competition and PatentTerm Restoration Act of 1984
• Was a response to pressure to
reduce drug costs
• Encouraged the creation of generic
drugs
• Extended patent licenses to allow
manufacturers to recoup research
and development costs
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Drug Price Competition and PatentTerm Restoration Act of 1984
• Generics are comparable
to brand name drugs in
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Dosage form
Safety
Strength
Quality
Performance
• Generics must demonstrate bioequivalence
to brand name product.
• Over 60% of prescriptions in community
pharmacies are filled with generics.
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Prescription Drug Marketing
Act of 1987
• Prohibits re-importation of drugs into
US by anyone but the manufacturer
• Passed in response to concerns over
safety and competition issues
• Has become a major issue as seniors
travel to Canada for prescriptions or
order medications by mail
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Anabolic Steroid Act of 1990
• Anabolic steroids are a
synthetic version of
testosterone.
• Abuse by athletes has been
widely reported.
• Adverse side effects are
serious and permanent.
• Act identifies anabolic
steroids as a Class III drug,
allowing greater restrictions.
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Omnibus Budget
Reconciliation Act of 1990
• Requires state standards of practice for
drug utilization reviews
• Pharmacist must screen for
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Therapeutic duplication
Drug-disease contraindication
Drug-drug interactions
Incorrect dosage or duration of treatment
Drug-allergy interactions
Clinical abuse/misuse
• Possibility of loss of Medicaid
reimbursements used to enforce rules
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Omnibus Budget
Reconciliation Act of 1990
Also requires pharmacist to offer to
review and discuss with the patient
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name and description of medication
dosage form
dose
route of administration
duration of drug therapy
action to take after a missed dose
common severe side effects or adverse effects
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Omnibus Budget
Reconciliation Act of 1990
Also requires pharmacist to offer to
review and discuss with the patient
—continued
– interactions and therapeutic contraindications,
ways to prevent the same, and actions to be
taken if they occur
– methods for self-monitoring of the drug therapy
– prescription refill information
– proper storage of the drug
– special directions and precautions for
preparation, administration, and use by the
patient
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Dietary Supplement Health
and Education Act of 1994
• FDA has limited
oversight in diet
supplement market.
• Manufacturers are
not required to
prove
– Safety
– Effectiveness
– Standardization
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Dietary Supplement Health
and Education Act of 1994
• Act provided definitions and
guidelines on diet supplements.
• FDA may only review “false claims”
advertisements and monitor safety.
• FDA may remove unsafe
supplements, but burden is on FDA to
prove that the product is unsafe.
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Health Insurance Portability and
Accountability Act of 1996
• HIPAA has wide-ranging provisions.
• For pharmacies, impact is mostly on
confidentiality of patient records:
– Must document and provide to patient
information on how health information is
safeguarded
– Must have an employee training
program with yearly renewals
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Food and Drug Administration
Modernization Act
• Passed to update labeling on
prescription medications
• Authorizes new drug application
(NDA) fees which are used by FDA to
accelerate review of new drugs
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Medicare Prescription Drug,
Improvement, and Modernization
Act of 2003
• Better known as Medicare Part D
• Provides prescription drug coverage to
patients eligible for Medicare
– Voluntary program
– Patients pay an extra premium
– Usually have a deductible
• Also established health/savings accounts
(HSAs)
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Combat Methamphetamine
Epidemic Act of 2005
• Methamphetamine
– Highly addictive stimulant
– Made from OTC products
• Restricts the availability of
products used to make it:
– Pseudoephedrine
– Ephedrine
• Products must be stored “behind the counter” and
purchases must be documented.
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National Oversight Agencies
• Food and Drug Administration (FDA)
• Drug Enforcement Administration (DEA)
• Occupational Safety and Health
Administration (OSHA)
• National Association of Boards of
Pharmacy (NABP)
• State boards of pharmacy
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Food and Drug
Administration (FDA)
• Under Department of Health and
Human Services (HHS)
• FDA’s Center for Drug Evaluation and
Research (CDER) impacts pharmacy:
– New drug development and review
– Generic drug review
– Over-the-counter drug review
– Post-drug approval activities
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Food and Drug
Administration (FDA)
• Primary responsibility and authority to
enforce the law
• Has no legal authority over the practice of
pharmacy in each state
• FDA activities
– Requires manufacturers to file applications for
investigative studies and drug approvals
– Provides guidelines for packaging and
advertisement
– Oversees the recall of dangerous products
– Produces annual Orange Book reference
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Food and Drug
Administration (FDA)
Safety Note
The FDA regulates OTC labeling so
it is understandable to a layperson.
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Terms to Remember
Drug Enforcement Administration
(DEA)
the branch of the US Justice Department
that is responsible for regulating the sale
and use of drugs with abuse potential
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Drug Enforcement
Administration (DEA)
• Most of its effort spent on illegal drug
trafficking, but also supervises legal
use of controlled substances
• Inspects medical facilities and
pharmacies; usually just those where
suspicious activity has been detected
• Maintains an audit trail of narcotics
from manufacturer to warehouse to
pharmacy to patient
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Drug Enforcement
Administration (DEA)
DEA registration is required for all individuals,
institutions, and businesses involved in
controlled substances, including
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Manufacturing
Distributing
Dispensing
Researching
Instructional activities
Detoxification programs
Importing / exporting
Compounding
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Drug Enforcement
Administration (DEA)
• CSA defines who may prescribe controlled
substances.
• Prescriptions must be written for a
legitimate reason related to the physician’s
practice (e.g., dentist can prescribe
narcotics for dental pain but not for back
pain).
• Except for emergencies, prescription must
be written rather than phoned or faxed.
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Occupational Safety and
Health Administration (OSHA)
• Ensures the safety and health of US
workers
• OSHA’s role in pharmacies, hospitals,
and home health care is to
– Protect against inadvertent needle sticks
– Ensure safe disposal of syringes
– Oversee policies to protect employees
from unnecessary drug exposures
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Terms to Remember
National Association of Boards of
Pharmacy (NABP)
an organization that represents the
practice of pharmacy in each state and
develops pharmacist licensure exams
reciprocation
the administrative process for
relicensure of pharmacists in another
state
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National Association of
Boards of Pharmacy (NABP)
• Has no regulatory authority
• Primary role is to develop national
pharmacist license examination
• Coordinates reciprocation of
pharmacists practicing in other states
• Provides guidance to state boards of
pharmacy
• Developed Model State Pharmacy
Practices Act for national continuity
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State Boards of Pharmacy
• Consist of leaders from the pharmacy
community and also consumer members
• Review applications and administer
examinations developed by NABP
• Maintain a database of active
pharmacists
• Inspect all new pharmacies
• Provide regulations regarding refilling of
prescriptions
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Legal Duties
of Pharmacy Personnel
• Role of the pharmacy tech
– Not defined by federal statute
– Not uniformly defined from state to state
– Constantly changing
• Some states limit the ratio of
pharmacy techs to pharmacists.
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Legal Duties
of Pharmacy Personnel
• Duties not required to be done by
pharmacists may be carried out by
the pharmacy technician.
• All technicians’ duties must be carried
out under the direct supervision of the
pharmacist.
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Duties Typically Performed
by Pharmacists
Dispensing, recordkeeping, and pricing
– receiving a verbal, or oral, prescription in person or
by telephone
– preparing the written form of the verbal prescription
from a doctor’s office or another pharmacy
– interpreting and evaluating prescriptions
– reviewing patient profile (e.g., medication history,
duplication of medications, allergies, drug
interactions)
– verifying and certifying records
– transferring prescriptions to other pharmacies
(See Table 2.5)
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Duties Typically Performed
by Pharmacists
• Preparing Doses of Precompounded
Medications
– checking/verifying finished prescriptions
• Preparing Doses of Extemporaneously
Compounded, Nonsterile Medications
– checking and verifying that drugs were selected
properly
– calculating weights and measures
– verifying that weighing and measuring were done
properly
– verifying finished product
(See Table 2.5)
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Duties Typically Performed
by Pharmacists
Transporting Medications to and from
floors/units in a hospital (especially
controlled substances)
– checking and verifying delivery records
– examining returned medications for
integrity and reusability
– emptying returned medications into
stock containers
(See Table 2.5)
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Duties Typically Performed
by Pharmacists
• Replenishing floor stocks (especially
controlled substances)
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checking and verifying
replenishing stocks
certifying and checking drug stations
disposing of unused items and discontinued
medications
• Verifying finished product against original
order or prescription
(See Table 2.5)
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Duties Typically Performed
by Pharmacy Technicians
Dispensing, recordkeeping, and
pricing
– receiving written prescriptions and
conveying them to the pharmacist
– answering and properly directing
telephone calls
– preparing records, including patient
profiles and billing records
(See Table 2.6)
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Duties Typically
Performed by Pharmacy
Technicians
Safety Note
Some states allow certified pharmacy
technicians to accept prescriptions
over the telephone.
Duties Typically Performed
by Pharmacy Technicians
Preparing Doses of Precompounded
Medications
– retrieving medications from shelf or supply
cabinet
– selecting containers
– preparing labels
– counting or pouring medications
– reconstituting prefabricated medications
– pricing prescriptions
(See Table 2.6)
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Duties Typically Performed
by Pharmacy Technicians
Preparing Doses of Extemporaneously
Compounded, Nonsterile Medications
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retrieving medications from shelf or supply cabinet
selecting equipment for the compounding operation
weighing and measuring
compounding
preparing labels
selecting containers
packaging
maintaining and filing records of extemporaneous
compounding
– cleaning area and equipment
(See Table 2.6)
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Duties Typically Performed
by Pharmacy Technicians
Transporting Medications to and from floors/units
– preparing cart, tray, or other means of
conveyance
– delivering controlled drugs
– maintaining delivery records
– distributing medications to wards
– organizing medications for administration to
patients
– retrieving, reconciling, and recording credit for
medications not administered
– returning unused medications to unit dose bins
and injectables to stock
(See Table 2.6)
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Duties Typically Performed
by Pharmacy Technicians
Safety Note
Some states allow a “tech check tech”
system in which one technician is
allowed to check another technician’s
work preparing unit dose carts.
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Duties Typically Performed
by Pharmacy Technicians
Replenishing Floor Stocks
– Checking for expiration dates
– Removing overstocks
(See Table 2.6)
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Terms to Remember
United States Pharmacopeia (USP)
the independent scientific organization
responsible for setting official quality
standards for all drugs sold in the United
States as well as standards for practice
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Terms to Remember
United States Pharmacopeia–National
Formulary (USP–NF)
a book that contains US standards for
medicines, dosage forms, drug
substances, excipients or inactive
substances, medical devices, and
dietary supplements
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United States Pharmacopeia
• Publishes United States Pharmacopeia–National
Formulary (USP–NF)
• Contains standards for
– Medicines
– Dosage forms
– Drug substances,
excipients, inactive
substances
– Medical devices
– Dietary substances
• Rose out of the FDC Act of 1938
• Recognized by FDA and accrediting agencies
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