 US Law falls under several categories:
 Criminal law: involves a crime against an individual specifically and
to society in general. Examples are 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
 Penalties
 Misdemeanor is a crime punishable by a jail term of 1 year or less
and/or a monetary fine
 Felony is a crime punishable by a jail term of greater than 1 year up
to life or death.
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
 FDA is charged with protecting the public by enforcing FDCA
 Label and Labeling requirements made by the FDCA.
 Labels are on the immediate container of the drug

Must include:
 established name of drug and quantity of each active ingredient.
 Statement of quantity
 Statement of usual dosage
 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)
 Additional label elements added through later
amendments
 National drug code
 FD&C yellow #5 (Tartazine) or yellow #6 if present
(human allergens)
 If aspartame is present must declare phenylalanine and
PKU warning
 If sulfites are present, must declare it
 If methysalicylate is present in concentration of over 5%
must state toxicity warning
 OTC label requirements
 Drug Manufacturer’s name and address
 Active ingredient(s)
 Inactive ingredients
 “Purposes” sections
 “Don’t use” section
 “Directions”
 “Questions” section provides an toll free number of
questions
 These requirements were added through amendments
to the FDCA over the years
Labeling requirements by the FDCA
 Labeling is the printed material that accompanies the medication
container. This is called the Package Insert and is required by the FDA
and is intended for use by healthcare clinicians
 Description of the chemical nature of the drug including its generic










name and chemical properties
Pharmacology
Indications for use
Contraindications-situation where the drug should not be used
Dose
Warnings
Side effect warnings
Adverse reactions
Drug Abuse potential, if applicable
How drug is supplied
Date of most recent revision to labeling
FDCA defines a drug
 FDCA defined a drug as: “article intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of
disease in man or animal”
 FDCA defines adulteration as:
 A product that is combined with an ingredient that reduces





its potency or quality, any putrid or decomposing substances
A product that is kept in unsanitary conditions
A product that contains unapproved colorants
Manufactured under conditions that are less than GMP’s
Claims to be a drug of USP standards but is differing in
quality
See text for additional information
 FDCA defines misbranding as “false and misleading labeling” or
dispensing or distributing a product in violation of its labeling
 Does not include the established name of the drug
 The name and/or address of the manufacturer is missing
 Failure to include Federal disclaimer or “Rx only” on legend drugs
labels (see Durham Humphrey) or dispensing a legend drug
without a prescription
 Sale of a drug under the name of another
 Failure to include “Warning –May be habit forming” if required on
its label
 See text for other provisions
 In general, adulteration involves the composition of the drug
products and misbranding involves misleading labeling
Amendments to the FDCA
 Durham Humphrey Amendment of 1951
 called the prescription drug amendment
 Established two classes of drugs: legend drugs that require a
prescription and OTC with does not
 required that legend drugs must have the federal legend: “Caution:
Federal law prohibits dispensing without a prescription”. Later in 1997,
legend was shorten to “Rx only”

Legend drugs not label with such are misbranded
 Allows prescribers to phone in Rx’s to pharmacies
 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.
 Also called the “Drug efficacy amendment”. Drug needed to be safe and
effective.
 Established marketing protocols for NDA’s
 Also regulate prescription drug advertising
Thalidomide Scare of 1950’s and
1960’s
 First used in Europe as a “wonder” drug for pain, and




insomnia. It was reported to be effective for treating
nausea and as a result it was used to treat morning sickness
in pregnant women.
The US FDA never allowed the drug to be marketed in the
US. Pregnant women obtained the drug from other
sources like across border trade and their husbands
returning from WWII active duty in Europe
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
pharmacists for dispensing.
 Drug has approval from the FDA for use in Erythema
Nodosum Leprosum and in multiple myeloma.
Other lesser known pharmacy laws
 1914: Harrison Narcotic Act : The possession of
narcotics and coca became illegal.
 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 abuse.
Listed with symbol “C” followed by a number from 1 to 5. 1 having the
highest potential for abuse and 5 the lowest.
 Established the Drug Enforcement Agency (DEA) under the US Dept
of Justice
 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, marijuana (weed), methaqualone (Luddes)






“Crack” cocaine
Crystal Methamphetamine
Hashish
Heroin
Phencyclidine palmitate (PCP) (angel dust)
Rohypnol (Roofies)
Schedule II Drugs
BRAND NAME
GENERIC NAME
Codeine ®
Codeine
Dolophine®
Methadone
Duragesic ®
Fentanyl
Astramorph, Duramorph ®
Morphine
Oxycontin ®, Roxicodone ®
Oxycodone
Adderall®
Amphetamine/dextroamphetamine
Amytal ®
Amobarbital
Cocaine 4% ®
Cocaine
Demerol ®
Meperidine
Percocet ®
Oxycodone/Acetaminophen
Dilaudid
Hydromorphone
Schedule III Drugs
BRAND NAME
GENERIC NAME
Bontril ®
Phendimetrazine
Vicodin ®, Loricet ®, Anexsia ®
Hydrocodone/APAP
Vicoprofen
Hydrocodone/ibuprofen
Tussionex
Hydrocodone/Chlorpheniramine
Soma with Codeine®
Carisoprolol/Codeine
Schedule IV Drugs
BRAND NAME
GENERIC NAME
Benzodiazepines (Ativan ®, Valium ®,
Tranxene ®, Librium ®, Restoril®)
Lorazepam, Diazepam, Chlorazepate,
Chlordiazepoxide, Temazepam
Fastin ®
Phenermine
Fioricet ® with Codeine
Butalbital, APAP, Caffeine, Codeine
Talwin ®
Pentazocine
Stadol ®
Butorphanol
Xanax ®
Alprazolam
Cylert ®
Pemoline
Robitussin AC ®
Guaifensin and Codeine
Schedule V Drugs
BRAND NAME
GENERIC NAME
Acetaminophen/Codeine Elixir
N/A
Lomotil ®
Diphenoxylate 2.5 mg/Atropine 0.025
mg
Lyrica ®
Pregabalin
Phenergan with Codeine ®
Promethazine with Codein
Exception to the CSA Drug
Schedules
 Some drugs are typical narcotics but because they are combined with
other less potent dugs with more side effects they are de-scheduled
from the CSA
 Additive are meant to discouraged abuse
 Examples




Pyridium Plus
(Butabarbital)
Librax ®
(Chlordiazepoxide/Clidinium Bromide)
Donnatal ® (Phenobarbital, atropine, hyoscyamine, scopolamine)
Anaspaz PB
(Hyoscyamine/Phenobarbital)
 Remember Fiorinal ® (Butalbital/Caffeine/ASA) is a scheduled drug
but Fioricet (Butalbital/Caffeine/APAP) is not
 Remember: BDZ are CIII federal, in NY they are CII
 Remember: Barbiturates are CIV except: Secobarbital (Seconal ®) and
Amobarbital (Amytal ®)
 Schedule II Drugs- General Guidelines
 prescriptions may be written for a one month supply
maximum with no refills.
 Have strong potential for abuse and have a medical
purpose
 Must use DEA 222 to order
 Must use DEA 106 form to report loss or theft
 Can be written, or electronic
 Can’t be faxed (ok in only limited circumstances)
 Can’t be called in (exemption Emergency Verbal)
 Scheduled III & IV Drugs
 Prescriptions can be written, phone in, faxed, or sent
electronically
 Can be filled for up to 5 refills or up to 6 months
 DEA 106 to report loss or theft
 Can be transferred to other pharmacy
Schedule drugs continued
 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.
 Can be phone in, written, faxed or electronically sent to a
pharmacy
 DEA 106 is filed for theft or loss
 Can be filled with out a prescription only under the
following conditions:
 Sold by a pharmacist
 Log book must be keep
 No more than 4 ounces or 24 solid dose forms in a 48 hour
period to a single patient
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.
 Drug name, dose, directions for use
 Quantity
 Refills (if any)
 A pharmacist can’t alter the name of the patient, drug, or the prescriber’s
signature. Under Federal law, other information can be altered with
prescriber’s permission
Security Requirements
 As per Federal Law, prescriptions for CII-CV can be
either locked up or dispersed.
 If CII are grouped together, they must be locked up in a
cabinet
 If CIII-CV are grouped together, they must be locked up
in a cabinet
 If controlled substances are not locked up, they must be
scattered among the pharmacy’s entire inventory
 Either group and Lock or Separate and scatter
 Record Keeping of Controlled Substances
 All invoices of controlled substances must be kept for two years
 DEA 222 must be attached to the corresponding invoice
 CII invoice must separate from other pharmacy invoices
 Biennial Inventory
 All scheduled controlled substances in house must be inventoried
every two years


Exact physically count of CII is required
Estimated count of CIII-CV is ok if products are container s with less than 1,000
count
 Controlled Substance Prescriptions
 Maintained on file for 2 years
 Options for filing



1. Three files- CII, CIII-CV, other legend drugs
2. Two files- CII, CIII-CV + other drugs (CIII-CV must have red “C” in corner)
3. Two files- CII-CV and other legend drugs (CIII-CV must have red “C” in corner)
 To destroy controlled substances
 Must notify DEA office and state narcotic office (NYS DOH Bureau
of Narcotic Enforcement) of Day and time of destruction
 DEA 41 is used to surrender drugs to the DEA directly
 To report theft of controlled substances
 Notify local police
 Notify DEA office
 State narcotic office
 Fill out DEA 106 form
 To order c2 drugs complete
 DEA 222 form
 To apply for a DEA registration
 DEA 224
DEA numbers
 DEA numbers are issued by the US Dept of Justice to
entities that prescriber, dispense, manufacturer, distribute
or export scheduled controlled substances
 Contains 2 letters with a 7 digit number
 1 st letter signifies the type of DEA registrant
 A/B/F are doctors, dentists, hospitals, clinics, pharmacies
 M are midlevel practitioners (PA, NP, etc)
 P/R are manufacturers, exporters, wholesalers, etc
 2 nd letter is part of the entity’s name (most often the first
initial of the last name)
 Six digits are the serial number
 Seventh digit is a checksum digit
DEA Number
 To verify if a DEA number is valid perform the
checksum algorithm
 First Add the 1st,3rd,5th digits together
 Second add 2nd,4th and 6th digits together and
multiply by two
 Third add the results of the two together and if it
match the check digit the DEA is valid. If not, the
DEA number is fraudulent
Penalties involving violations of the
CSA of 1970
Simple Posession of Controlled Substances (21 USC
844)
Drug or Class
Fine
Imprisonment
C II –C V(First
offense)
Not less than
$1,000
Up to 1 year
C II- CV
(Second Offense)
Not less than
$2,500
15 days to 2 Years
Any Offense
(Flunitrazepam
$250,000
Upto 3 years
Marihuana
(possession of a
small amount)
Not Less than
$1,000
Up to 1 year
Penalties for Violations of CSA of
1970
Drug Trafficking (Possession with intent to distribute) 21 USC 841,960,962
Drug or Drug
Class
Amount
Fine
Imprisonment
Heroin
1 kilo or more
$10,000,000 or
more
10 years to life
Cocaine or Coca
leaves, Ecgonine
5 kilos or more
>=$10,000,000
10 years to life
PCP
(Phencyclidine)
100 grams or more
>=$10,000,000
10 years to life
LSD (lysergic acid
Diethylamide)
10 grams or more
>=$10,000,000
10 years to life
Methamphetamine
50 grams or more
>=$10,000,000
10 years to life
Fentanyl
400 grams or more >=$10,000,000
10 years to life
Drug or Class
Amount
Fine
Imprisonment
Flunitrazepam and 1 gram or more
GHB (see below)
GHB (any amount)
$1,000,000
Up to 20 years
Any other C1 or CII Any weight
$1,000,000 or more
Up to 20 years
C III
Any weight
$500,000 or more
Up to 15 years
C IV
Any weight
$250,000 or more
Up to 5 years
CV
Any weight
$100,000 or more
Up to 1 year
The above table contains that maximum penalty for jail time or amounts that
are less than the one above the fine and penalties are less.
These listed offenses are for first time offenses
Flunitrazepam (Rohypnol® or street name of “Roofies” is a benzodiazepine
that produces powerful sedation and anterograde amnesia. It is a “date rape
drug” and has been used in committing sexual assault in the US and other
countries. GHB (gamma hydroxybutyrate) is similar to flunitrazepam and is
a date rape drug also known as “Georgia Home Boy","Lollipops"
Rockefeller Drug Laws
 In 1973, NYS governor Nelson Rockefeller signed in law one




of the most draconian state drug laws in the US.
Anyone with illegal possession with intent to sell 57 grams
or more of heroin, cocaine, marihuana, morphine would
sentenced to a minimum of 15 years
Anyone with illegal possession of 113 grams or more of the
above drugs would serve 15 years to life.
Due to political pressures, governors George Pataki and
David Patterson greatly reduced these minimum sentences
to class D felonies and for marihuana a misdemeanor
Criminal possession of prescription narcotics is still a
felony in most cases in NY
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.




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
 Result of a decade long dispute between generic drug





manufacturers and brand drug manufacturers
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
necessity of going through extensive efficacy and safety testing.
Did not sit well with large brand drug companies. To help these
drug manufacturers recoup their costs the term of brand drug
patents were extended by an additional five years
Called “generic drug act”
Also called the Hatch Waxman act
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) 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 medicaid patients. This
requirement later extended to all patients depending on the state of
residency.
 Required the pharmacist to perform a DUR, drug utilization review to
screen for:





Drug interactions
Therapeutic duplicates
Drug disease interactions
Wrong dosing
Abuse of medications (earlier refills)
 Created a need for pharmacy technicians to assist pharmacists in the
technical aspects 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 protected health information (PHI)be safeguarded by the
healthcare industry.
 Medical records need to be safeguarded electronically which may involve
encryption coding and password protection.
 Patient’s rights under HIPAA include:
 Access to their own health information
 Ability to amended information
 Ability to control to whom PHI is disclosed
 Receive written notification of how PHI may be used by the health provider also
know as “notice of privacy practices”
 When PHI is used by a provider for any reason other than treatment or
payment, explicit authorization must be obtained from the patient.
 Portability refers to the ability to transfer insurance provision from one
employer to another
 Requires pharmacy to appoint a HIPAA compliance officer
Penalties for HIPAA violations
 Civil Penalties: up to $25,000 fine
 Criminal Penalties are incurred if the entity knowingly
using PHI unlawfully
 $50,000 and 1 year in prison
 $100,000 and 5 years in prison if entity obtains PHI
under false pretenses
 $250,000 and 10 years in prison if entity sells PHI for
personal gain or for malicious harm to patient’s
reputation
Ancillary Laws
 Poison Prevention Packaging Act of 1970
 Required childproof dispensing containers for all Rx drugs
 Elderly people who desire non child resistant container must sign a waiver.
 A prescriber can waive the requirement by only for one prescription at a time (no
blanket authorization)
 Drug exceptions to the PPPA are sublingual nitroglycerin, oral contraceptives in the
memory package dial, erythromycin ethylsuccinate tablets, Mebendazole Tablets,
Pancrelipase preparations, among others see text on page 52
 Conditional Exceptions
 patients in hospitals
 For OTC products with more than one strength, one strength can be marketed
with out this package if the following is on the package: “Not for households
with young children”
 Upon dispensing a refill, the pharmacist must used a new plastic vial and cap to refill
the prescription due to the high wear and tear of Rx vials
 Prescription Drug Marketing Act of 1987
 Passed to stop the passage of counterfeit drugs into the
marketplace and to stop unfair monetary gain from
illegally procured drugs
 Made it illegal for retail pharmacies to have in its
possession Rx drug samples from the manufacturer
 Hospital Pharmacies were not allowed to resale drug
obtained through discounted pricing.
 Prevents the reimportation of drug into the US except
by the drug manufacturer
 Think of it has the “prescription drug samples act”
 Medical Device Amendment of 1976
 Life saving medical devices were required to have
premarket approval by the FDA
 Example is a cardiac pacemaker and defibrillators
 The Drug Listing Act of 1972
 Amendment to FDCA
 Required all drugs to have an NDC code
 NDC’s have three parts



First set of five numbers-Manufacturer
Second set of four numbers-drug product
Third set of two numbers-package size
 Medicare Prescription Drug, Improvement, and
Modernization act of 2003
 Provides prescription drug coverage for medicare participants
 Provides for medication therapy management (MTM) where
pharmacist can receive compensation for this
 Also called the Medicare Modernization act (MMA)
 Medicaid Tamper Resistant Prescription Act of 2007
 Due to high federal cost of funding medicare and medicaid,
the government mandated that doctors implement
counterfeit proofing strategies of their prescription pads
 Does not apply if an Rx is faxed, phoned or electronically sent
directly to the pharmacy
 Online Pharmacy Consumer Protection Act of 2007
 Also called the Ryan Haight Act
 Ryan Haight was a 17 year old teen who died from an overdose
of vicodin ® obtained from an internet based pharmacy. Ryan
posed as a adult male with severe back pain
 Established guidelines for online pharmacies
 Must display compliance with this law on the site’s homepage
 Defined that a Rx for a controlled substance must be for a
legit medical reason AND involves at least one in person
medical evaluation
 Occupational Safety and Health Act of 1970
 Created OSHA agency
 Addresses workplace safety from hazardous substances
 Addresses air quality, flammable and explosive chemicals,
and hazardous drugs
 Requires a reporting system for job related injuries
 Requires the use of SDS-Safety Data Sheets (also called MSDS
M=Material)


SDS are required to be distributed by manufacturers of hazardous
chemicals or drugs to the purchaser
SDS provides users of such with data on Hazards, fire aid measures
of exposed, fire fighting methods, handling and storage, Physical
and chemical properties, stability and reactivity
 Resource Conservation and Recovery Act of 1976
 Known as the RCRA
 Established different classes of hazardous waste materials




F listed (industrial solvents)
K listed (specific industrial wastes)
P listed (finished commercial drug products that are acutely toxic)
includes warfarin, nicotine, physostigmine, epinephrine (Adrenalin)
U listed (finished commercial drug products that are subacutely
toxic). Most chemotherapy drugs
 Most Pharmacies use a vendor that handles and disposes
hazardous drugs for them in compliance with the RCRA
 FDA Modernization act of 1997
 Changed the disclaimer of “caution-Federal law prohibits
dispensing without a prescription” first established with the
Durham Humphrey Act to simply “Rx only”
 Drug Addiction Treatment Act of 2000
 Referred to as DATA2000
 Before this law, only MDs licensed to prescribe methadone for
opiate/Heroin addiction can write for methadone for this purpose
and only in setting of a clinic licensed by the state and federal
government as a detoxification maintenance provider
 With this law, MD’s can be licensed to prescribe Buprenorphine
based products for office based treatment of addiction


Suboxone (Buprenorphine) and Subutex (Buprenorphine/Naloxone)
This MD have the DEA number of X+ 7 digits