I. OBJECTIVE: To provide proper action regarding Product Recall
To establish coordination with the supplier/s when a certain product is recalled.

II. SCOPE: All products that are subjected to be recalled under the DOH-FDA declaration.

III. RESPONSIBILITY

* Pharmacist * Owner/Manager

IV. PROCEDURE

1. The pharmacist is important person to accomplish this task. 2. The distributor company will inform the drugstore about the product recall through a Product Recall Letter* containing the details of product/s to be recalled. 3. The pharmacist must be particular on the batch no or lot no of the product that is being recalled from the market to facilitate removal of stock in the shelves and the store. 4. After the batch no has been checked, see to it that the product is removed from the shelves so that it will not be sold anymore. 5. Coordinate to the supplier when will be the product withdrawn. 6. Wait for further pronouncement of the recall to be updated.

V. QUALITY OF RECORDS:

The letter and withdrawal form should be kept for further purposes.

VI. FORMS:

Logbook

VII. END OF DOCUMENT

GOOD DISPENSING

I. OBJECTIVE: To provide standard operating procedure for Dispensing Prescription Drugs.
To insist use of generic equivalent drugs which are cost-effective in nature.

II. SCOPE: All prescriptions, generic equivalent drugs and Over-The-Counter drugs.

III. RESPONSIBILITY

* Pharmacist * Pharmacy Assistant

IV. PROCEDURE

1. Greet the client with a smile. 2. Receive the prescription in a dignified manner. 3. Read the prescription properly the name, strength, dose and quantity. If in case of doubt ask the pharmacist. 4. Check the legality and legibility of the prescription. 5. If the prescription is illegible of in case of doubt, confirm with the doctor over phone. Do not dispense a prescription drug without a proper prescription order and do not dispense when doubting. 6. After that check for the availability of the stock and make sure that the product is the one that said in the prescription order. Make sure that the product is under the good condition and the expiration date is still far. 7. Give the client the chance to choose what is the most cheap but quality and effective when use. 8. Obtain the medicines from the gondola, double check if it is the medicine in the prescription order, and ask for the quantity to be bought. 9. Check the product in front of the customer and interpret the instruction of the doctor to him or give relevant information regarding the storage, administration and etc. 10. Proceed to the billing and an official receipt should be issued.

V. QUALITY OF RECORDS:

The pharmacist will file the fully filled prescription and shall be input in theprescription book.
The prescriptions will be kept for 2 years.

VI. FORMS:

Prescription order and prescription book

VII. END OF DOCUMENT

Objective: * To ensure that the drugs being distributed by the supplier is safe and effective. * To have a team that will monitor and recall the products in case FDA requires a drug to be recalled from the market.

Scope: * All products in the market voluntarily recalled by pharmaceuticalcompany or issued by FDA.

Responsibility: * Pharmacist

Procedure: * Upon receipt of a case report, the FDA Committee for product recall will assess the hazard presented through issuance of drug recall. Such case report may come from the responsible company (company volunteering), FDA technical divisions, DOH or other government offices, or consumercomplaints. * The Committee will submit a written recommendation to the FDA director for the issuance of a recall order or to confirm a company initiated recall. * The concerned DOH offices will be informed of the decision to orderproduct recall. * A Public Health Alert will be issued within twenty-four (24) hours for cases that have bee determined as Class 1 or Class II Recall. * If recall is not firm-initiated, a notification will be issued to the firm regarding the recall recommendation together with a request for the submission of recall plan/procedure and other information listed in Section 6.2. * An in-depth inspection of responsible establishment/production facilities where the violation occurred will be conducted by the concerned inspection division of FDA. * If necessary, other DOH units and government agencies will be utilized in implementation of the recall. * The concerned FDA inspection division will audit the recall operation by developing and implementing a recall audit program. * In case the concerned firm refused to conduct a product recall, regulatory action and/or other measures will be pursued by FDA. * The FDA will determine when the recall will be terminated and upon such determination, provide written notification of the termination of the recalling firm.

Quality of Records: * Pharmaceutical companies should decide and record all final actions taken on all recalled goods. It should also take care of all stored goods with proper instruction until the final action is not taken on the recalled goods.

Forms: * Batch Distribution Logbook

End of Document

PRODUCT PROCUREMENT

I. OBJECTIVE: To provide proper guidelines in procuring of stocks.

II. SCOPE: Applied to all products

III. RESPONSIBILITY

* Pharmacist * Owner/Manager

IV. PROCEDURE

1. The procurer will make an order through phone, SMS, facsimile, sales representative and other media. 2. There should be a copy or list of the products to facilitate checking of them when delivered. 3. Upon delivery of the product, check the product's count, amount, batch no. and make sure that the expiry date is very far to make sure the product is safe and effective. 4. The procurer will pay the delivery man and ask for official receipt and copy of the sales invoice and filed them. 5. The procurer will price the product through an acceptable price mark-up. 6. The product will then display and ready to be sold.

V. QUALITY OF RECORDS:

The purchaser will file the invoice for future use and other case.

VI. FORMS:

Logbook

VII. END OF DOCUMENT

GOOD STORAGE PRACTICE

I. OBJECTIVE: To have standard operating procedure for Storage of Medicines.

II. SCOPE: All products that within the drugstore. Should be under specific temperature for other temperature-sensitive drugs and proper categorized.

III. RESPONSIBILITY

* Pharmacist * Owner/Manager * Pharmacy Assistant

IV. PROCEDURE

1. After initially checking the medicines delivered, all products should be wrapped by a clear plastic to avoid accumulation of dust particulates. 2. Transfer the goods to their respective areas. 3. Store the goods in an organized and orderly manner with the label bearing the name of the product in front. 4. First-Expire-First-Out will be the basis of disposing drugs. 5. Avoid direct contact to the sun or on the walls to avoid moisture accumulation. 6. Store controlled drugs substances and other potent drugs in the designated. Access this area should only be allowed to the pharmacist and owner. 7. Store expired goods in the storage room, marking it with “Expired” to prevent use. 8. Store medicines at stipulated temperature areas, protected from excessive light, dust and humidity. The temperature should be checked by thepharmacist daily and recorded in the monitoring sheet if necessary for cold chain drugs. 9. Store the other stock in a separated area. Maintain all sales invoice records for return or exchange of products to the supplier. 10. Clean and maintain the storage areas neat and tidy all the times.

V. QUALITY OF RECORDS: N/A

VI. FORMS: N/A

VII. END OF DOCUMENT

Standard Operating Procedure – Drug Distributor: Good Procurement/Distribution Practice

Objective: * To establishment a system of procurement/distribution practice to ensure that all drugs are of high quality. Valued and suited for human consumption.

Scope: * Examine all company where drugs are procured for quality and safety.

Responsibility: * Pharmacist

Procedure: 1. Submit all procured drugs to FDA for compliance. 2. There should be documented quality policy describing the overall intentions and policies of the establishment regarding quality. 3. Systematic actions necessary to ensure adequate confidence that a product (or service) and documentation will satisfy given requirements for quality.

Quality Records: * All drugs should be listed/ to be monitored any incoming drugs as to stocks, expiry date. * To develop a system or procedure for procurement/distribution.

Forms * Distribution Logbooks

End of Document

Good Housekeeping

I. OBJECTIVE: To produce a proper guidelines regarding the cleanliness of the drugstore.

II. SCOPE: Within the vicinity of the drugstore and cleaning of the shelves and good housekeeping.

III. RESPONSIBILITY

* Pharmacist * Pharmacy Assistant

IV. PROCEDURE

1. Use a clean cloth for cleaning the shelves, clean mop with detergent or bleaching agent in cleaning the floors. 2. Transfer the medicines from the shelves to an empty box. 3. Wipe the shelves and clean it with cloth to remove dust. 4. In case of rigid smudges/stains, use damped cloth to clean them. 5. After completion, place the medicines back to where they belong. 6. Wash and dry up the cloth used in cleaning. Repeat cleaning every week. 7. Clean the floor with mop. 8. Throw the garbage when the time of collection is near. Do not place it outside because scavengers might scatter it. 9. Try to search for pest and make necessary action to eliminate them.

V. QUALITY OF RECORDS: N/A

VI. FORMS:

Logbook for cleaning

VII. END OF DOCUMENT