OVERVIEW OF PHARMACY (Simplified)
Origins and Important People
Pharmakona – Greek word where “pharmacy” came from; means a charm or a drug that can be
used for good or bad.
Ebers Papyrus – A 60-foot scroll from ancient Egypt with over 800 drug formulas and 700+
drugs. Found by Georg Ebers in a mummy’s tomb and now kept in the University of Leipzig.
Hippocrates – Greek doctor known as the Father of Medicine. Started the scientific practice of
pharmacy and medicine.
Pedanios Dioscorides – Greek doctor and botanist. Wrote De Materia Medica, an important
book about using plants for medicine.
Claudius Galen – Greek doctor-pharmacist. Created many drug mixtures from plants. His work
led to the term “Galenic pharmacy.” Known for Galen's Cerate (cold cream).
Emperor Frederick II (Germany) – Signed a law in 1240 AD that separated pharmacy from
medicine.
Paracelsus – Real name Aureolus Theophrastus Bombastus von Hohenheim. A Swiss doctor
who changed pharmacy from using just plants to using chemicals too.
Karl Wilhelm Scheele – Swedish pharmacist who discovered many acids (like citric, tartaric) and
oxygen (before Priestley). He also identified glycerin.
Friedrich Sertürner – German pharmacist who discovered morphine from opium.
Joseph Caventou & Joseph Pelletier – Discovered quinine and cinchonine (from cinchona) and
strychnine and brucine (from nux vomica).
📚 DEFINITION OF TERMS (Simplified)
Drug – A substance used to diagnose, treat, prevent, or cure diseases in people or animals.
Active Ingredient – The part of the drug that actually works in the body.
Excipient – The inactive part of a drug (like fillers, flavorings, etc.).
Dosage Forms – The form of the medicine (like tablets, syrups) that carries the active ingredient
into the body.
Drug Delivery System – A tool or method that controls how and where the drug works inside the
body.
Medical Devices – Tools or machines used for diagnosing, treating, or monitoring diseases in
people.
📖 UNITED STATES PHARMACOPEIA (USP) and NATIONAL FORMULARY (NF)
Pharmacopeia – From Greek words “drug” and “to make.” It means a book of official drug
,formulas.
1580 – First use of the word pharmacopeia in Italy.
1778 – First American pharmacopeia published for the U.S. Army.
1817 – Dr. Lyman Spalding (Father of USP) proposed a national pharmacopeia.
1820 – First USP Convention met and published the first USP in English and Latin.
1864 – UK combined its 3 city pharmacopeias into British Pharmacopoeia (BP).
1888 – APhA created the National Formulary (NF).
1906 – U.S. law made USP and NF official drug standards.
1975 – USP bought NF, creating a single compendium: USP–NF.
Today – USP–NF is updated every year and available in print and online.
⚖ DRUG REGULATION AND CONTROL (Simplified)
Laws
Food and Drug Act of 1906 – First U.S. law to regulate locally made drugs.
Sherley Amendment – Banned false claims about what a drug can do.
Federal Food, Drug, and Cosmetic Act of 1938 – Requires FDA approval before selling new
drugs.
Durham-Humphrey Amendment (1951) – Divided drugs into prescription and over-the-counter
(OTC).
Kefauver-Harris Amendments (1962) – Drug makers must get FDA approval before testing new
drugs on humans (through an IND).
Controlled Substances Act (1970)
Schedules I–V classify drugs based on medical use and abuse risk:
Schedule Meaning
I No accepted medical use; high abuse risk (e.g., heroin, LSD)
II Medical use but high abuse risk (e.g., morphine, cocaine)
III Lower abuse risk; may cause moderate dependence (e.g., codeine)
IV Low abuse risk; may cause mild dependence (e.g., diazepam)
V Lowest abuse risk (e.g., cough meds with small amounts of codeine)
🤰 FDA PREGNANCY CATEGORIES (Simplified)
,Category Meaning
A Safe in pregnant women
B Animal studies show no risk, but no full human studies
C Risk in animals, not tested in humans; may still be used if needed
D Human studies show risk, but drug may be needed anyway
X Proven harmful; never use during pregnancy
⚠ BLACK BOX WARNING
A strong FDA warning in drug labels about serious or life-threatening risks.
Given if:
Risk is high compared to benefits.
Serious side effects can be prevented with care.
FDA restricts how it’s used to make it safer.
🗂 OTHER IMPORTANT DRUG LAWS
Drug Listing Act (1972) – FDA can list all drugs in the market to make sure they’re safe and
legal.
Orphan Drug Act (1983) – Gives rewards (like tax cuts and exclusive selling rights) to
companies that develop drugs for rare diseases.
Drug Price Competition and Patent Term Restoration Act (1984) – Allows companies to sell
generic drugs without repeating full studies, through ANDA.
Prescription Drug Marketing Act (1987) + Amendment (1992) – Protects drug supply from fake
or mislabeled drugs.
Prescription Drug User Fee Act (1992) – Drug companies pay FDA to speed up drug approval
process.
Dietary Supplement Acts (1994 & 2006) – Supplements can’t claim to treat or cure diseases.
💊 PHARMACEUTICAL CARE (Simplified)
Pharmacists help people use their medicine safely and correctly.
Pharmaceutical care means giving direct, responsible care to patients using medicines to
improve their quality of life.
It's patient-centered, focused on:
Preventing and treating disease,
, Working with other health providers,
Monitoring and adjusting medications to make sure they are safe and effective.
Main goal: Help the patient stay healthy while using medicine wisely and affordably.
INVESTIGATIONAL NEW DRUG (IND) APPLICATION
IND Application: A request submitted to the US FDA asking for permission to start human
testing of a new drug and to ship it before getting marketing approval.
→ The sponsor (company or researcher) must show enough lab and animal data to prove it’s
safe to test on humans.
Types of IND Applications:
Investigator IND – Submitted by a doctor who wants to study a new drug.
Emergency Use IND – For using a new drug in an emergency when there’s no time for full
approval.
Treatment IND – For giving a promising but unapproved drug to seriously ill patients.
Screening IND – For using multiple drugs to find the best one for future studies.
NEW DRUG APPLICATION (NDA)
NDA: An application sent to the US FDA asking for permission to sell a new drug.
→ It includes animal and human test results, drug actions, side effects, proper dose, and how
it’s made.
ABBREVIATED NEW DRUG APPLICATION (ANDA)
ANDA: An application to get approval to sell a generic drug, which is a copy of a brand-name
drug that’s already approved.
SUPPLEMENTAL NEW DRUG APPLICATION (SNDA)
SNDA: A request to update an already-approved NDA. It may include:
New way of making the drug
Moving the manufacturing location
Changing the formula
Updating testing methods or tools
Changing the packaging
Extending the drug’s expiration date
SOURCES OF NEW DRUGS
Origins and Important People
Pharmakona – Greek word where “pharmacy” came from; means a charm or a drug that can be
used for good or bad.
Ebers Papyrus – A 60-foot scroll from ancient Egypt with over 800 drug formulas and 700+
drugs. Found by Georg Ebers in a mummy’s tomb and now kept in the University of Leipzig.
Hippocrates – Greek doctor known as the Father of Medicine. Started the scientific practice of
pharmacy and medicine.
Pedanios Dioscorides – Greek doctor and botanist. Wrote De Materia Medica, an important
book about using plants for medicine.
Claudius Galen – Greek doctor-pharmacist. Created many drug mixtures from plants. His work
led to the term “Galenic pharmacy.” Known for Galen's Cerate (cold cream).
Emperor Frederick II (Germany) – Signed a law in 1240 AD that separated pharmacy from
medicine.
Paracelsus – Real name Aureolus Theophrastus Bombastus von Hohenheim. A Swiss doctor
who changed pharmacy from using just plants to using chemicals too.
Karl Wilhelm Scheele – Swedish pharmacist who discovered many acids (like citric, tartaric) and
oxygen (before Priestley). He also identified glycerin.
Friedrich Sertürner – German pharmacist who discovered morphine from opium.
Joseph Caventou & Joseph Pelletier – Discovered quinine and cinchonine (from cinchona) and
strychnine and brucine (from nux vomica).
📚 DEFINITION OF TERMS (Simplified)
Drug – A substance used to diagnose, treat, prevent, or cure diseases in people or animals.
Active Ingredient – The part of the drug that actually works in the body.
Excipient – The inactive part of a drug (like fillers, flavorings, etc.).
Dosage Forms – The form of the medicine (like tablets, syrups) that carries the active ingredient
into the body.
Drug Delivery System – A tool or method that controls how and where the drug works inside the
body.
Medical Devices – Tools or machines used for diagnosing, treating, or monitoring diseases in
people.
📖 UNITED STATES PHARMACOPEIA (USP) and NATIONAL FORMULARY (NF)
Pharmacopeia – From Greek words “drug” and “to make.” It means a book of official drug
,formulas.
1580 – First use of the word pharmacopeia in Italy.
1778 – First American pharmacopeia published for the U.S. Army.
1817 – Dr. Lyman Spalding (Father of USP) proposed a national pharmacopeia.
1820 – First USP Convention met and published the first USP in English and Latin.
1864 – UK combined its 3 city pharmacopeias into British Pharmacopoeia (BP).
1888 – APhA created the National Formulary (NF).
1906 – U.S. law made USP and NF official drug standards.
1975 – USP bought NF, creating a single compendium: USP–NF.
Today – USP–NF is updated every year and available in print and online.
⚖ DRUG REGULATION AND CONTROL (Simplified)
Laws
Food and Drug Act of 1906 – First U.S. law to regulate locally made drugs.
Sherley Amendment – Banned false claims about what a drug can do.
Federal Food, Drug, and Cosmetic Act of 1938 – Requires FDA approval before selling new
drugs.
Durham-Humphrey Amendment (1951) – Divided drugs into prescription and over-the-counter
(OTC).
Kefauver-Harris Amendments (1962) – Drug makers must get FDA approval before testing new
drugs on humans (through an IND).
Controlled Substances Act (1970)
Schedules I–V classify drugs based on medical use and abuse risk:
Schedule Meaning
I No accepted medical use; high abuse risk (e.g., heroin, LSD)
II Medical use but high abuse risk (e.g., morphine, cocaine)
III Lower abuse risk; may cause moderate dependence (e.g., codeine)
IV Low abuse risk; may cause mild dependence (e.g., diazepam)
V Lowest abuse risk (e.g., cough meds with small amounts of codeine)
🤰 FDA PREGNANCY CATEGORIES (Simplified)
,Category Meaning
A Safe in pregnant women
B Animal studies show no risk, but no full human studies
C Risk in animals, not tested in humans; may still be used if needed
D Human studies show risk, but drug may be needed anyway
X Proven harmful; never use during pregnancy
⚠ BLACK BOX WARNING
A strong FDA warning in drug labels about serious or life-threatening risks.
Given if:
Risk is high compared to benefits.
Serious side effects can be prevented with care.
FDA restricts how it’s used to make it safer.
🗂 OTHER IMPORTANT DRUG LAWS
Drug Listing Act (1972) – FDA can list all drugs in the market to make sure they’re safe and
legal.
Orphan Drug Act (1983) – Gives rewards (like tax cuts and exclusive selling rights) to
companies that develop drugs for rare diseases.
Drug Price Competition and Patent Term Restoration Act (1984) – Allows companies to sell
generic drugs without repeating full studies, through ANDA.
Prescription Drug Marketing Act (1987) + Amendment (1992) – Protects drug supply from fake
or mislabeled drugs.
Prescription Drug User Fee Act (1992) – Drug companies pay FDA to speed up drug approval
process.
Dietary Supplement Acts (1994 & 2006) – Supplements can’t claim to treat or cure diseases.
💊 PHARMACEUTICAL CARE (Simplified)
Pharmacists help people use their medicine safely and correctly.
Pharmaceutical care means giving direct, responsible care to patients using medicines to
improve their quality of life.
It's patient-centered, focused on:
Preventing and treating disease,
, Working with other health providers,
Monitoring and adjusting medications to make sure they are safe and effective.
Main goal: Help the patient stay healthy while using medicine wisely and affordably.
INVESTIGATIONAL NEW DRUG (IND) APPLICATION
IND Application: A request submitted to the US FDA asking for permission to start human
testing of a new drug and to ship it before getting marketing approval.
→ The sponsor (company or researcher) must show enough lab and animal data to prove it’s
safe to test on humans.
Types of IND Applications:
Investigator IND – Submitted by a doctor who wants to study a new drug.
Emergency Use IND – For using a new drug in an emergency when there’s no time for full
approval.
Treatment IND – For giving a promising but unapproved drug to seriously ill patients.
Screening IND – For using multiple drugs to find the best one for future studies.
NEW DRUG APPLICATION (NDA)
NDA: An application sent to the US FDA asking for permission to sell a new drug.
→ It includes animal and human test results, drug actions, side effects, proper dose, and how
it’s made.
ABBREVIATED NEW DRUG APPLICATION (ANDA)
ANDA: An application to get approval to sell a generic drug, which is a copy of a brand-name
drug that’s already approved.
SUPPLEMENTAL NEW DRUG APPLICATION (SNDA)
SNDA: A request to update an already-approved NDA. It may include:
New way of making the drug
Moving the manufacturing location
Changing the formula
Updating testing methods or tools
Changing the packaging
Extending the drug’s expiration date
SOURCES OF NEW DRUGS
