[DISPENSING-LEC-FINALS] CH9: PROPER LABELING

Label

This refers to a display of written, printed, or graphic matter upon the immediate container of the drug product and a requirement set by the FDA.

Labeling

This means all labels and other written, printed, or graphic present in the containers and wrappers or accompanying product such thereof.

Labeling materials

This refers to the label in the immediate container, and the other printed materials that are made available with the product.

AO No. 55 s. 1988

The DOH has issued requirements for labeling materials of Pharmaceutical Products through this Administrative Order as amended through AO 64 s1989.

• Food, Drugs, and Cosmetics Act

• Generics Act of 1988

AO No. 55 s. 1988 is the pursuant to these two acts.

Generic name

It is required that this shall be the one with the highest point size among the printed elements of the label, printed in full and enclosed exclusively by and outlined box.

Generic name

Information needed in Labeling Materials:

This refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients determined by the FDA.

Brand name

Information needed in Labeling Materials:

This refers to the proprietary/trade name assign to the product by the drug establishment.

Pharmacologic category

Information needed in Labeling Materials:

This refers to the classification of the product based on its therapeutic action as specified in the product registration.

Formulation

Information needed in Labeling Materials:

This refers to the name(s) of active medicinal ingredient per dosage unit expressed in the metric system.

Indication

Information needed in Labeling Materials:

This refers to the approved critical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form.

Dosage form

Information needed in Labeling Materials:

This means the pharmaceutical form of the preparation based on official pharmacopeia.

Mode of administration

Information needed in Labeling Materials:

This refers to the site and manner the product is to be introduced into or applied to the body.

Warnings

Information needed in Labeling Materials:

This refers to statements regarding the conditions wherein the use of the product may cause harm to the patient.

Contraindications

Information needed in Labeling Materials:

This refers to statements regarding the occurrence of potential hazards and side effects as associated with the use of the product and the limitation of its use.

Precautions

Information needed in Labeling Materials:

This refers to the instructions and special care required to use the product to avoid undesired effects and ensure the safe and effective use of the drug.

Date of manufacture

Information needed in Labeling Materials:

For products other than biological products means the date (month and year) during which processing of the bulk product, from which the goods are to be filled, is completed.

Batch number

Information needed in Labeling Materials:

This refers to any distinctive combination of letters and/or numbers assigned to a particular batch herein defined as any product produced during a given cycle of manufacture.

Batch number

This permits the production history of the batch including all stages of manufacture and control, to be traced and reviewed.

Lot number

Information needed in Labeling Materials:

This refers to any distinctive combinations of letters and/or numbers assigned to a particular lot, herein defined as a portion of a batch.

Expiration date

Information needed in Labeling Materials:

This refers to the date after which the product is not expected to retain its claimed safety, efficacy, and quality or potency or after which it is not permissible to sell, distribute, or use said product.

Net content

Information needed in Labeling Materials:

This refers to the total amount/quantity/number of the dosage form in particular container of a product expressed in the metric system.

Storage condition

Information needed in Labeling Materials:

This refers to the prevailing specified range of temperature, humidity, and other environmental factors which optimal stability of the product is ensured based on laboratory data.

Rx symbol

Information needed in Labeling Materials:

If its is a prescription drug.

Section 36 of Article II of Republic Act 10918

Current guidelines on labeling for dispensed medicine can be found under?

Section 36 of Article II of Republic Act 10918

It states that upon every box, bottle, or package of medicines compounded or dispensed by a registered and licensed pharmacist based on prescription.

RA No. 9502

“Universally Accessible Cheaper and Quality Medicines Act of 2008”

White labels

These are usually used to label loose capsules and tablets, suspensions, etc., that are taken orally.

This pertain to those that are not packed in strips or blisters.

Oral use

The “white” term denotes drugs that are intended for?

Red labels

These are used to label compounded medicines that are externally used.

Warning: For External Use Only

The red label must have a warning notice to avoid confusion and misuse.

External Use

The “red” term denotes that the drug is labeled for its?

Good Compounding Practice

Packaging and labeling go together as part of?

6 months

The New Expiration Date or Beyond-Use Date (BUD) should be how many months from the date the bottle was opened?

Beyond-Use Date

BUD stands for?

Diluent

The liquid is also termed as?

Compounded Sterile Preparations

CSP stands for?