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US Pharmacy Law
 American law preceded through many stages.
 On July 4th, 1776 the 13 colonies declared independence from
England’s King George. After a few months , The Articles of
Confederation, was drafted among the 13 founding states that
established the United States of America as a confederation of
sovereign states and served as its first constitution .
 On March 4, 1789, the Articles were replaced with the US
Constitution, which provided for a stronger central government.
It provided for a division of powers into executive (president),
judicial (supreme court), and legislative (Congresational)
branches. It also delineated rights to its citizens that are granted
by their creator and can’t be taken away called the bill of rights
(i.e. freedom of speech, freedom of religion, and due process)
 US Constitution is the supreme law of the land and all
proceeding laws and statutes (laws passed by congress
or state senates) must conform to it. This is call
constitutionality.
 From the constitution, the US congress and state
senates promulgate laws or statutes. Often these laws
establish regulatory bodies to help enforce these laws.
For example the Food and Drug Agency was
established by the Food, Drug, and Cosmetic Act of
1938 to help enforce the regulations of the act.
 US Law falls under several categories: (1)
 Criminal law: involves a crime against an individual
specifically and to society in general. Murder, rape, sexual
assault, burglary, grand larceny. It is brought to trial by a
district attorney or prosecutor who seeks an indictment or a
conviction of a crime by a jury to the offender.
 Civil law (tort law): deals with dispute resolution between
individuals and/or organizations. Emphasis is on
compensation and not on punishment. Most cases of
medical malpractice fall under this category. Medical cases
that result in death can be heard here as “wrongful death”
cases.
 Family Law
Important Milestones in Pharmacy
law
 Pure Food and Drug Act of 1906: forbade the manufacture,
sale and distribution of adulterated medications as well as
meat and poultry products.
 Food, Drug, and Cosmetic Act of 1938 established the Food
and Drug Administration which oversees the production of
drugs, cosmetics and food products in terms of certain
standards. Standards are:
 Manufacturers of drugs are required to submitted safety data
before they can market any drug.
 Requirements for label and labeling of drugs
 Only a licensed prescriber can write for drugs for certain
conditions. However, the distinction between OTC and
Legend drug were not distinct.
 Label and Labeling requirements made by the FDCA.
 Labels are on the immediate container of the drug
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Must include:
 established name of drug and quantity of each active ingredient.
 Statement of new quantity
 Statement of usual dosage
 Federal legend (Durham Humphrey)
 Route of administration
 If habit forming, federal disclaimer
 Name of all inactive ingredients if not for oral use
 Name and address of manufacturer, packer or distributor
 Lot number and expiration date
 Specific container to be used by the pharmacist to dispense
medication (i.e. dispense in an amber vial for light sensitive
drugs)
 Label elements required on a dispensed prescription.
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Names of prescriber, patient, and pharmacy (and address)
Serial number of prescription
Original Date of fill
Expiration date or number of refills
Directions for use
Cautionary Statements (if needed)
Curiously, no mention is made of the name of the drug or its
dosage or the pharmacist’s or technician’s name.
FDCA defines a drug
 FDCA defined a drug as: “articles intended for use in
the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or animals”
 FDCA defines adulteration: “a product that is
combined with an ingredient that reduces its potenty
or quality” (3)
 FDCA defines misbranding as “false and misleading
labeling” (4)
 Penalties for violations of the FDCA include
restraining orders and seizures of above products
Amendments to the FDCA
 Durham Humphrey Amendment of 1951: required that
legend drugs must have the legend: “Caution: Federal
law prohibits dispensing without a prescription”. This
act established the difference between OTC and
legend drugs.
 Kefauver Harris Amendment of 1962: established that
drugs be proven safe and effective before they are
marketed to the public.
 Act came about because of the thalidomide tragedy.
Thalidomide Scare of 1950’s and
1960’s
 First used in Europe as a “wonder” drug for pain, and
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insomnia. It was reported to be effective for treating
nausea and as a result used to treat morning sickness by
pregnant women.
The US FDA never allowed the drug to be marketed in the
US. Pregnant women obtained the drug from other
sources across border trade and from samples given to
them by doctors in the US.
Birth defects have been linked to the drug even after only
one dose.
This was proven by 1961.
The defect involved an absence/malformation of limbs in
the fetus called phocomelia.
Thalidomide syndrome
Thalidomide Today
 Thalidomide was removed from the worldwide market
in 1962-1963.
 Today however the drug is market in the US under the
brand name Thalomid® under very strict conditions
and requires registration with the STEPS program
(system for thalidomide education and prescribing
safety). The program is monitored by the FDA and
requires registration by doctors, patients and
pharmacist for dispensing.
 Drug has approval from the FDA for use in Erythema
Nodosum Leprosum and in multiple myeloma.
 Thalidomide is an example of a drug where the
labeling includes US black box warnings.
 These warnings are encircled with a black outlined box
and contains very important information that must be
made to health care professionals.
Other lesser known pharmacy laws
 1914: Harrison Narcotic Act : The possession of
narcotics and coca became illegal without a
prescription.
 1924: Heroin Act: The manufacture and the possession
of heroin became illegal.
 1927: Bureau of Prohibition: enforces the 18th
amendment to the US constitution.
 1937: Marijuana Tax Act: requires payment of a tax to
buy cannabis. Illegal to do so without payment.
The Comprehensive Drug Abuse
Prevention and Control Act of 1970
 Established five schedules of drugs that have high potential for
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abuse. Listed with symbol “C” followed by a number from 1 to 5.
1 having the highest potential for abuse and 5 the lowest.
Standards are set in each class that helps law enforcement
prevent diversion and to protect the public.
Schedule I: have no accepted medical use in the US. Includes
Heroin (smack), LSD (angel dust), marijuana (weed).
Schedule II: prescriptions may be written for a one month supply
with no refills; must be written an a triple prescription in most
states. Examples include morphine, fentanyl, hydromorphone,
Percocet®, Codeine tablets, Demerol® (mepiridine), Ritalin ®
(methylphenidate), Adderall ® (mixed amphetamine salts)
Schedule III: prescription may be written for five refills to be
used in a 6 month period. Includes Vicodin®, Lorcet ®, and
Tylenol ®
Schedule drugs continued
 Schedule IV: same requirement as CIII’s. Includes
benzodiazepines and barbiturates. In NYS,
benzodiazepines are CII agents. Examples of
benzodiazepines are Ativan® (lorazepam), Valium®
(diazepam), Xanax ® (alprazolam), Restoril ®
(temazepam).
 Schedule V: includes cough preparation with codeine.
Example is Tussin C® (Guaifenesin with Codeine). Up
to 11 refills are allowed like a regular prescription and is
valid for one year.
Other provision of the CSA
 All individuals handling controlled substance are required to
register with the DEA (Drug Enforcement Agency which is a
branch of the US Dept. of Justice). This includes MD’s, drug
companies, distributors, pharmacies (not individual
pharmacists).
 A prescription for a controlled substance must have the
following to be dispensed:
The full name and address of both prescriber and patient.
DEA of the prescriber
Date prescription was written
Signature of the prescriber.
If any of the following are missing, the prescription can not be
filled.
 Corrections can be made the pharmacist in consultation with the
prescriber but the above elements can not be altered.
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Controlled substances in NY
 States, via their own laws, can make the CSA laws more
strict, but can’t make them more loose.
 According to the CSA, benzodiazepines are CIV agents but
in NY they are treated like a CII agent.
 In NY, a prescriber is allowed to phone in a verbal
prescription to the pharmacy for a controlled substance;
however, the following apply:
 Only a five day supply of the medication can be supplied in
the case of CII and CIII.
 The prescriber must submitted a written prescription to the
pharmacy in that period of time.
 No refill are allowed.
The Orphan Drug Act of 1983
 Passed by congress to provide incentives for drug companies to
create drugs for rare diseases in which the profit motivation is
not there.
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Seven year market exclusivity
50% tax credit in the cost of conducting clinical trials.
Research grants
Waive the costs of submitting fees to the FDA.
Example is a drug called Aldurazyme® made by BioMarin
Pharmaceuticals (California based company with the ticker symbol:
Nasdaq: BMRN). It is an enzyme that is lacking in a genetic disease
called Hurler’s syndrome. People with Hurler’s are often disfigured
with gargoyle like features. They are often mentally retarded with
other neurological features. They also have failing organs in
particular the liver. They often will die by about 10 years of age
because of liver disease.
The Drug Price Competition and
Patent Term Restoration Act of
1984
 Allowed manufacturers of generic drugs to file an
Abbreviated New Drug Applications (ANDA) with the
FDA.
 Allowed these companies to show that their generic
drugs where therapeutically equivalent to their brand
competitors without the neccessity of going through
extensive clinical testing.
 Allowed the influx of cheap drugs in the US
marketplace.
Anabolic Steroid Control Act of
1990
 Placed anabolic steroids in the CIII category.
 Hormones that are pharmacological similar to
testosterone
 Responded to high rate of steroid abuse in young teens
and athletes (Mark McGuire and Barry Bonds).
 Example of such drugs: Anadrol® (oxymetholone),
Decadurabolin® (nandrolone), and Winstrol ®
(stanozolol).
Omnibus Budget Reconciliation act
of 1990 (OBRA 90)
 Passed by congress to address the rising cost of the
medicaid and medicare programs
 Required pharmacist to counsel all medicare and
medicaid patients. This requirement later extended to
all patients.
 Created a need for pharmacy technicians to assist
pharmacists in the technical aspect of pharmacy to
allow them to devoted more time to the clinical
aspects of pharmacy practice.
The Health Insurance Portability
and Accountability Act of 1996
 Known as “HIPAA”
 Requires that personal medication information be
safeguarded by the healthcare industry.
 Medical records need to be safeguarded electronically
and more importantly established that consent must
be given by the patient to transmit this data from
healthcare practitioner to a third party.
 Consent must be given to fill a prescription by the
person for whom the prescription is written.
The Pharmacy Technician’s Code of
Ethics
 Adopted by the American Association of Pharmacy
Technicians and the National Pharmacy Technician
Association.
 American Association of Pharmacy technicians can be
reached at 1-877-368-4771. or at
pharmacytechnician.com
 National Pharmacy Technician Association can be
reached at 1-888-247-8700 or at
pharmacytechnician.org