Pharmacy Law & Ethics

Laws governing the practice of pharmacy

By: Taha M. Maaroof
B.Sc., M.Sc.
Intro…
• Pharmacists employed in all pharmaceutical sectors must be aware of the legal
requirements that apply to their daily professional activities.

• There are different laws that govern the practice of pharmacy. Among these the
following are the major ones:

• 1-Food, drug and cosmetic Act of 1938

• 2-Controlled substances Act of 1970

• 3-Poison Prevention Packaging Act of 1970

• 4-Commercial law
 Food, drug and cosmetic Act (FDCA)

• Providing the basis for categorizing drugs as prescription only and non-
prescription drugs
• A drug will be prescription only if it depicts either of the following.
• 1- It is habit forming
• 2-It is not safe for self medication
• 3-It is a new drug that has not been proved to be safe.
• The act requires that prescription only drugs should be labeled as “Law
prohibits dispensing without prescription”
FDCA…

• In general, Food, Drug and Cosmetic Act and its amendments are designed to prevent two

evils, tribulations -

• 1-Adulteration and

• 2-Misbranding of drug products

• Adulteration relates to the impurity of product via change of composition of the product.

• Misbranding deals primarily with labeling violations.

FDCA…
• A drug is deemed to be adulterated if

• 1- It consists in whole or in part any filthy, putrid or decomposed substance.

• 2- It has been prepared, packed or held under insanitary condition

• 3- It was manufactured, processed, packed or held under conditions that

don’t comply with the FDA’s CGMP regulations.

• 4- Its container is composed of any poisonous or deleterious substance that

may render the drug injurious to health.

• 5- If its strength differs from its labeled strength

FDCA…
• A drug will be considered misbranded if:
• 1-Its labeling is false or misleading in any particular part
• 2-Its label doesn’t bear the name & address of the manufacturer, packer or distributer as
well as an accurate statement of the quantity of the contents.
• 3-It contains a habit-forming substance specified in the regulations & doesn’t bear the
statement warning.” May be habit-forming” directly adjacent to the name of the agent.
• 4-It doesn’t bear the name of the agent and its labeling doesn’t bear adequate directions
for use & is not in accordance with compendia standards.
• 5-Its container is so made, formed or filled as to be misleading
• 6-It was manufactured or processed in a plant that was not registered.
• 7- Its packaging and labeling are not in conformity with the poison prevention packaging
Act of 1970.
FDCA…

• According to the FDCA or its amendments, nonprescription drugs

must bear a seven point label:
• 1-The name of the product
• 2-The name & address of the manufacturer, packer or distributor
• 3-The net contents of the package
• 4-The name & quantity of all ingredients
• 5-The name of any habit forming drug contained in the preparation
• 6-Cautions & warnings needed for the protection of the user
• 7-Adequate directions for safe & effective use.
Controlled substances Act (CSA)

• The CSA is the legal basis by which the manufacture, importation,

distribution, delivery & dispensing of drugs or substances that have the
potential for physical & psychological dependence and abuse are regulated.

• The Act created five schedules/ classifications with varying qualifications

for a drug to be included in each.

• The classification was made on the criteria of potential for abuse, accepted
medical use and potential for addiction.
 CSA…
Schedule I

• The drugs under this category have:

• High potential for abuse
• No accepted medical use
• Lack of safety
• Ex: Marijuana, Heroin, Ecstasy (3,4 methylenedioxymethamphetamine), LSD (Lysergic acid
diethylamide), PCP (Phencyclidine), Crack cocaine, Methamphetamine.
CSA…
Schedule II
• The drugs in this category have:
• High potential for abuse
• Accepted medical use
• Severe psychological or physical dependence
• Ex. Oxycodone, Morphine, Amphetamine salts, Methylphenidate (Ritalin),
Cocaine.
CSA…
Schedule III

• Lesser abuse potential than I & II

• Accepted medical use
• Moderate or low physical & high psychological dependence
• Ex: Ketamine, Anabolic steroids, Testosterone
CSA…
Schedule IV
• Less abuse potential than III
• Accepted medical use
• Lower dependence than III
• Clonazepam, Alprazolam, Diazepam, Lorazepam, Midazolam
CSA…
Schedule V
• Lowest abuse potential & dependency
• Have accepted medical use
• Ex. Cough syrups containing codeine, Anti-diarrhea containing diphenoxylate,
Pregabalin, Lacosamide (Vimpat)

• The quantity of substance in a drug product often determines under which

schedule it will be controlled.
• For e.g. Amphetamines & codeine are generally included in schedule II. However,
certain products containing smaller quantities are controlled in schedules III & V.
Poison Prevention Packaging Act
• This act was created to decrease the risk of accidental poisoning in children and prevents hundreds of deaths that
were occurring annually from children accidentally ingesting medications and household chemicals.

• It requires that most prescription and over-the-counter products be packaged in materials that are resistant to opening
by children. Containers are considered by this act to be child-resistant if they cannot be opened by 80 percent of
children under 5 but can be opened by 90 percent of adults.

• There are some exceptions to the requirement for child-resistant packaging. These include:

• 1- If the patient requests non-child-resistant packaging in a signed statement, a blanket authorization may be given
for all of a patient’s medications.

• 2-If the prescriber requests non-child-resistant packaging, a blanket authorization may be given for all of a patient’s
medications.

• 3-Specific medications do not require child-resistant packaging, including:

• ○○ Less than 12.6 mg of betamethasone per package.

• ○○ Aerosol sprays for inhalation.

• ○○ Less than 600 mg of mebendazole per package.

• ○○ Less than 105 mg prednisone per package. And …

Commercial law
• Pharmaceutical trade is a combination of trade and professional activities; hence it is
affected by commercial law

• Commercial law is a loose term of all those rules related to how a business ought to be
fairly conducted. It includes:

• 1-The law of private product ownership

• 2-The law of insurance plan

• 3-The law of business ownership

• 4-The law of contract

Law of private product ownership
I. Patent law
• A patent is an exclusive right granted by a government to exploit an invention.

• Although it differs in detail from one country to another, it is intended to protect

the inventor from others who would like to profit from the invention.

• Patents are often enforceable internationally

• Patents can completely shield a product from competition for the period of the
patent 17 to 25 years
Law of private product ownership cont..
II. Trade mark law

• A trade mark is a product trade name and description of its package, which a
producer is likely to register in countries, where the product is being distributed.

• The trade mark is the means by which a product is recognized, therefore, it is vital
that other companies be protected from marketing products that would be easily
confused with the original.
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