[ BFAD MEMORANDUM CIRCULAR NO. 8, June 06, 1990 ]
CLARIFICATION ON THE RULES AND REGULATIONS GOVERNING DISPENSING AND DRUG OUTLETS LICENSING REQUIREMENTS
Section 1.3, A.O. 63 s. 1989: Partial filling of prescription means dispensing less than the total number of units prescribed, or less than the total number of drug products prescribed on the same prescription form.
Section 3.3, A.O. 63 s. 1989: In partial filling of the prescription, the following shall be written on the face of the prescription:
1. the date of the partial filling
2. the number of units or drug product(s) served and balance of the prescription unserved; and
3. name and address of the drugstore.
The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes the filling of the prescription shall keep the prescription in file.
Section 3.4.3, A.O. 63 s. 1989: The prohibition against the partial filling of prescription of products listed in list A of A.O. 63 shall not be considered in effect: as such, products listed in list A as Dangerous Drugs shall be governed by prescription and dispensing requirements of DDB.
SECTION 2. Recording in PrescriptionBook - Recording of prescription filled in the drugstore s official Prescription Book may be accomplished not later than the end of each quarter to comply with Section 2.3 of A.O. 63 s. 1989. A computerized data base containing the same information as the Prescription Book will be considered substantial compliance.
Prescriptions shall be filled consecutively and systematically as filled for easy retrieval during inspection and/or when the need arises and shall be available for inspection to Food and Drug Regulation Officers or duly authorized NDP Monitor at anytime during business hours.
SECTION 3. Required Information . - A handbook or directory and "MENU CARDS" or poster containing the list of drug products using generic names with their brand names, if any, and their corresponding current prices of each of the products listed. A sample of a Menu Card is provided herein.
"Menu Card"Generic Name: Ampicillin Trihydrate Dosage Strength and Form : 250 mg Capsule Brand Names: Manufacturer Prices 1. Amopen Mead Johnson 2.96 2. Aldribid Aldril 2.32 3. Aldril Ampicillin Aldril 2.30 4. Alfercin Alfer 2.34 5. Allidcil APL 2.78 6. Amcil Warner Lamber 2.80 7. Amcillin Regent 3.00 8. Amdricil Sydenham 2.78
SECTION 4. Recording of the Actual Product Dispensed (Implementing Section 3.2 of A.O. 63 s. 1989). - For purposes of specifying and recording of the actual product dispensed, the Generic Name and Company s Name shall be noted on the reverse side of the prescription filled before said prescription is filed. The Company s Name shall refer to the manufacturer s or trader s name indicated on the label of the drug product actually dispensed.
SECTION 5. Reporting of Violative Prescription - Keeping violative and erroneous prescription in file for the inspection and collection by BFAD Inspectors or authorized NDP Monitor is considered substantial compliance to the reporting requirements under Section 4.0 of A.O. 63 s. 1989.
SECTION 6. Penalties - Drug outlets are reminded that the following administrative penal sanctions may be imposed for violation of the Rules and Regulations governing dispensing or A.O. 63 s. 1989 as amended (and herein clarified), to wit:
"7.1 Suspension, or revocation of the license to operate the drug outlet by the Secretary of Health; and
7.2 Professionals directly involved in the violations shall be recommended by the Secretary of Health for appropriate administrative sanctions by the PRC."
Further Section 41 of R.A. 5921 provides for the following penalties, thus:
"Any pharmacist who shall violate any of the provisions of Sections twenty-eight, thirty, thirty-one, thirty-two, thirty-three, thirty-four, thirty-five, thirty-seven and thirty-eight of this Act or any pharmacist after his certificate of registration has been lawfully suspended or revoked, who continues to engage in the practice of pharmacy, shall, upon conviction thereof, be sentenced to a fine of not less than one hundred pesos but shall not exceed five hundred pesos or to an imprisonment of not less than thirty days but not more than four months, in the discretion of the court."
Section 38 of the same R.A. 5921 provides that:
"Every pharmacist who dispenses, sells or delivers any drug which falls under the classification of the Food and Drug Administration (BFAD) as potent drugs shall do so only upon prescription of a duly licensed physician, dentist or veterinarian."
SECTION 7. R eference Books and Documents - In the implementation of Section 2.2.1.2 of A.O. 56 s. 1989, the availability of any one of the required reference books for Drug Outlets in Sections 2.2.1.22, 2.2.1.2.6 and 2.2.1.2.7 of the said Order shall be considered as substantial compliance.
Adopted: 6 June 1990
(SGD.) CECILE P. GONZALEZ |
Director |