DDS LECT, 1st Semesters

Drug

An agent intended for use in diagnosis, mitigation, treatment, cure, or prevention of disease

Federal Food, Drug, and Cosmetic Act, 1938

A federal act for diagnosis, treatment, cure, or prevention of diseases in humans or in other animals

Drugs

refer to the pharmaceutical products that pertains to chemical compounds or biological substances

What is the intented use of drugs?

-Treatment

-Prevention

-Diagnosis of disease

Philippines Pharmacopeia, USP, BP

These are articles recognized in official pharmacopeias, these are drugs basically drugs and medicines listed in these reference books.

Modified True or False? Articles intended for use in MEDICATION, CURE, MITIGATION, TREATMENT, or prevention of disease in ONLY for humans. Covering prescription and OTC

Correct answers:

-DIAGNOSIS

-FALSE, Humans and Animals are included

What other examples of Articles (other than food) intended to affect the structure or any function of the body of humans or animals?

-Hormonal drugs

-Supplements, that influence the body function

Republic Act No. 9502

Are defined what act for Herbal or traditional drugs?

Medicines

drugs in appropriate dosage forms [assured quality, safety, and efficacy] for humans or animals, or both.

Pharmaceutical products

These are drugs, medicines, biologicals, pharmaceutical and biopharmaceuticals products/specialties…etc.

Define Pharmaceuticals products (8)

-Drug

-Medicines

-Biologicals

-Pharmaceutical

-Biopharmaceutical products/specialties

-Veterinary products

-Veterinary biologies

-Veterinary medicinal products

Over-the-counter (OTC) medecines

used for symptomatic relief of minor ailments, which can be dispensed without a prescription.

Pharmacist-only OTC medicines

Over-the-counter medicines classified by appropriate government, obtained only from licensed pharmacist

Prescription/Ethical medicines

only dispensed by a Pharmacist to a patient.

Prescription/Ethical medicines can only dispensed to the patient… if? (3)

-Valid prescription from dentist

-Dentist

-Veterinarian

Pharmaceutical outlets

entities licensed by appropriate agencies, and which are involved in [compounding and/or dispensing] directly to patients or end users

Pharmaceutical establishments

are involved in the [manufacture, importation, exportation, repacking, and distribution] of pharmaceutical products to outlets

Pharmaceutical manufacturers

Establishment engaged in any of all operations in the production of pharmaceutical products including in the preparation, processing, compounding, formulating…etc.

What operations does Pharmaceutical manufacturers engaged in? (15)

-Preparation

-Processing

-Compounding

-Formulating

-Filling

-Packaging

-Repacking

-Altering

-Ornamenting

-Finishing

-Labeling

-Preparatory

-Storage

-Sale

-Distribution