Ra 3720 definitions

Immediate container

does not include package liners.

Cosmetics

for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles.

New drugs

(1) any drug the composition of which is such that said drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs (as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof.)

Food

articles used for food or drink for man, chewing gum, and articles used for components of any such

Batch number

A designation printed on the label of a drug or device that identifies the batch and permits the production history of the batch including all stages of manufacture and control, to be traced and reviewed

Containing new fixed combination of drug either by molecular or physical combination Containing newly discovered active ingredient Intended for new indications In a new mode of administration In an additional dosage or strength of dosage

A drug is considered new when it is...?

Batch

A quantity of drug and device produced at a given cycle of manufacture

New Veterinary drugs

Drugs intended for use in animals including any drug intended for use in animal feeds

Expiry or expiration date

Means the date stated in the label of a drug or device after which the drug is expected to retain its claimed safety, quality and efficacy or potency or after which it is not permissible to sell

Distribute

Means the delivery or sale of drug or device for purposes of distribution in commerce

Import

Means to bring into the phils by sea, land or air

Export

Means to bring out of the phils by sea, land or air

Label

a display of written, printed, or graphic matter upon the immediate container of any article and a requirement made by or under authority of 3720

New drugs

any drug the composition of which is such that said drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

Drug

articles (other than food) intended to affect the structure or any function of the body of man or animals; and

Drug

articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

Cosmetics

articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof

Drug

articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them

Labelling

means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

Device

means instruments, apparatus, or contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or (2) to affect the structure or any function of the body of man or animals.