Dosage Forms and Drug Delivery System

Lectures

Drug Regulation and Control

Food and Drug Act of 1906

- first federal law in US to regulate drug products

- required drugs marketed to comply to claimed standards.

Federal Food, Drug and Cosmetic Act of 1928

- creation of FDA to administer and enforcement

- prohibits new drug or drug product without the filing of NDA and approval of FDA

Food and Drug Administration Modernization Act of 1997

Mission protect the public health against risks associated with the production, distribution, and sale of food

and food additives, human drugs and biological

radiologic and medical devices, animal drugs and feeds and cosmetics.

New regulations Patient access to investigational drugs for AIDS, cancer, Alzheimer disease

and other life-threatening illnesses.Faster drug approvalIncentives for investigational drugs for

children.

Responsibilities of FDA

• Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.

• Protecting the public from electronic product radiation.• Assuring cosmetics and dietary supplements are safe and

properly labelled.• Regulating tobacco products.• Advancing the public health by helping to speed product

innovations.

FDA mandated laws in the Philippines

• RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008, 

• RA 6675, or  The Generics Act Of 1988, • RA 5921, or The Pharmacy Law,• RA 9211, or The Tobacco Regulation Act of 2003• RA 7394, or The Consumer Act of the Philippines• RA 7581/10623, or The Price Act• RA 10611, or The Food Safety Act of 2013• RA  8172, or The ASIN Law,• RA 8203, or The Special Law on Counterfeit Drug• RA 8976, or The Food Fortification Law

FDA mandated laws in the Philippines

• RA 9165, or The Comprehensive Dangerous Drugs Act

• RA 9257, or The Expanded Senior Citizens Act of 2003

• PD No. 881, or The Household Hazardous Act• EO No. 51, or The Milk Code of the Philippines• RA 10354, or The Responsible Parenthood and

Reproductive Health Bill of 2012• PD 856, or The Code of Sanitation of the Philippines

History of FDA in the Philippines

• Francisco Duque Sr. created a subcommittee on Food and Drugs in the year 1961-62 to initiate an administration bill to Congress.

• The Subcommittee on Food and Drug was chaired by the then Undersecretary for Special Health Services, Dr. Rodolfo Caños, with members Dr. Trinidad Pesigan, Director of the Bureau of Research and Laboratories, Mr. Emilio Espinosa of the Bureau of Health Services, Ms. Amor Cita M. Pallera, Pharmacy Adviser, Office of the Secretary of Health, also as Secretary and Liaison to Congress.

• June 22, 1963 Republic Act No. 3720 was passed into law known as the “Food, Drug and Cosmetic Act”.

Durham-Humphrey Amendment of 1952

Rx ONLY Drugs that are considered useful only after expert diagnosis or too dangerous for self medication.

OTC Drugs that are safe enough for self medication/ treatment.

Without doctors’ prescription.

Legend drugs cant be refill without MD’s approval.

Kefauver- Harris Amendments of 1962

• Ensures a greater degree of safety for approved drugs. Manufacturers are required to prove a drug is both safe and effective before granted FDA approval for marketing.

Comprehensive Drug Abuse Prevention and Control act of 1970

• Consolidate and codify control authority over drugs of abuse into a single statue.

• Drugs such as stimulants, depressants, narcotics and hallucinogens were repealed and replaced by DEA.

• Republic Act 9165, or the Comprehensive Dangerous Drugs Act of 2002 was signed on June 7,2002 and took effect on July 4, 2002.

• President Gloria Macapagal Arroyo

Schedule I

• Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse.

• Most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence.

• heroin, lysergic acid diethylamide (LSD),

marijuana (cannabis),

3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote

Schedule II

• Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, less abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical dependence.

• also considered dangerous. • cocaine, methamphetamine, methadone, hydromorphone

(Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin

Schedule III

• Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence.

• Drug abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV.

Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone

Schedule IV

• Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence.

• Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien

Schedule V

• Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics.

• Drugs are generally used for antidiarrheal, antitussive, and analgesic purposes.

• Cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin

Black Box Warning

• Considered as FDAs strongest labeling requirements for high risk medicines.

• Patients on antidepressants calls for close monitoring.

Drug Listing Act of 1972

• Gives FDA with legislative authority to compile a list of marketed drugs to assist in the enforcement of federal laws.

• Must register with FDA and submit appropriate information for listing.

• NDC 0081-1541-12

MANUFACTURER

Drug Formulation (trade package, size and type)

Drug Price Competition and Patent Term Restoration Act of 1984

• Generic version of a drug can be filed thru ANDA• FDA evaluates chemistry, manufacturing, control standards

and bioavailability.• 5-20 years patent for innovative new drug.

Prescription Drug Marketing Act of 1987

• Intended to reduce risks of adulterated, misbranded, repackaged or mislabelled drugs to enter market through secondary sources.

• AKA Dingell bill and Drug Diversion Act

• Vitamins, Minerals, Amino Acids, Botanicals are not considered drug if FDA has not reviewed them.

• Disclaimer must appear on the product:“This product is not intended to diagnose, treat, cure or prevent

diseases.

Dietary Supplements Health and Education Act of 1994.

Code of Ethics of a Pharmacist

1. A pharmacist places the well being of the patient at the center of professional practice.

2. A pharmacist promotes the welfare of each individual in a caring and compassionate manner.

Code of ethics of a Pharmacist

3. A pharmacist serves the needs of the individual, community and society and provides health for all.

4. A pharmacist respects the rights of patient and upholds confidentiality of patient records.

5. A pharmacist acts with honesty, integrity and professionalism in relationship with the patient and other health professionals.

Code of Ethics of a Pharmacist

6. A pharmacist respects the abilities, values and contributions of colleagues and other health professionals and work with the closely to ensure better patient care.

7. A pharmacist is committed to continuously enhance professional competence.

Code of Ethics of a Pharmacist

8. A pharmacist, in coordination with the government and other health professionals helps in the formulation and implementation of health care policies, standards and programs designed for the benefit of society.