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Administrative Order No. 63 s.

1989
SUBJECT: Rules and
Regulations to Implement
Dispensing Requirements
under the Generics Act of 1988
(R.A No. 6675)
 Pursuant to Section 9 in relation to Section
6 (a) and 6 (d) of RA 6675 known as
“Generics Act of 1988”, and the pertinent
provisions of RA 3720 known as ”Food, Drug
and Devices and Cosmetics Act”, as
amended by Executive Order No. 175 s 1987.
RA 5921 known as the Pharmacy Act of 1972,
as amended. The following rulesd and
regulations are hereby promulgated.
Section 2. Guidelines On Dispensing
Based on Prior Laws
2.1. Prescription or Ethical Drugs.
These drugs can only be dispensed upon a
written order of a validly-registered physician ,
dentist or veterinarian.
2.2. Non – Prescription or OTC drugs.
These drugs maybe dispensed without a
written order of physician, dentist or
veterinarian. When dispensing OTC drugs
without Prescription, the pharmacist shall give
the necessary information and direction for use
of the drug.
2.3. All prescriptions dispensed in the drugstore, botica
or hospital pharmacy shall be kept in the file for two
(2) years and recorded in a prescription book
registered by BFAD which shall open for Inspections to
Food and Drug inspectors at any time during business
hours of the outlet.

Section 3. Additional Guidelines on Dispensing to


Implement the Generic Act of 1988

3.1 All drug outlets are required to practice


generic dispensing, with some exceptions,
modifications or qualifications in certain cases or
circumstances.
3.1.1. Drug Stores, Boticas and other Drug
outlets.

3.1.1.1. Inform the patient of all available


drug products generically equivalent to the one
prescribed with their corresponding prices.

3.1.1.2. For this purpose, all drug outlets


shall post in a conspicuous place in their
establishment a list of drug products with
generic names with their corresponding
current prices.
3.1.2 Hospital Pharmacies

3.1.2.1 Upon admission, the patient or


his/her responsible relative shall indicate in the writing
whether he/she shall submit to the hospital drug
policies or reserve the option to buy drugs or medicines
outside of the hospital pharmacy.

3.1.2.2 Hospital pharmacies operating on


acceptable formulary system and pricing policy as
determined by the DOH, and using generic
terminologies in procurement, prescribing, dispensing
and recording of the drugs shall be exempted from the
following:
3.1.2.2.1 Recording of prescriptions filled in the
prescription book and shall kept in file for two
(2) years.
3.1.2.2.2 Individually informing the
in-patient/buyer on the available generic
equivalents and their corresponding prices.

3.2 In dispensing to the buyer, drug products in


unit dose or products which are not in their
original containers but transferred to small
bottles, tin cans, boxes, plastics and/ or paper
envelopes and the like.
The pharmacist shall place legibly on
the required drug outlet’s label the
following:
• Name of the patient
• Generic name of the drug
• Brand name
• Manufacture
• Dosage strength
• Expiry date
• Directions for use
• Name of the pharmacist
3.3. In the partial filling of the
prescription, the following shall be
written on the face of the
prescription:

1. the date of the partial filling


2. quantity served and the
balance of the prescription unserved.
3. name and address of the drug
store
3.4 Dispensing Drugs in List A and List B
In dispensing drugs included in List A ( Prohibited and
Regulated Drugs)
And list B (Drugs requiring strict precautions in their use.)
attached in Annex and B respectively, the following shall be
observed:
3.4.1 dispensing must be done by the
pharmacist who shall affix his/her signature on
the prescription filled.
3.4.2 the order and instructions of the
doctor as written on the prescription must be
precisely followed
3.4.3 partial filling of the prescription for
drugs belonging to list A shall not be allowed.
Section 4. Guidelines on what to do with
violative, erroneous and impossible
prescriptions
4.1 Violative and impossible
prescriptions shall not be filled. The
pharmacist shall advice the prescriber of the
problem or instruct the customer to get the
proper prscription. The violative/impossible
prescription shall be kept and report in to
nearest DOH office.
4.2 Erroneous shall be filled, but they
shall be kept and reported to the nearest DOH
office for appropriate action.
Section 5. Violation on the part of dispensers and
outlets
The following acts or omissions are considered
violations of the rules and regulations.

5.1 Imposing on particular brand or product on


buyer
5.2 Inaccurate dispensing i.e dispensing a drug
product which does not meet the prescription as to
any or all of the following active ingredient, dosage
form and strength.
5.3 Failure to post or make accessible the
required up-to-date information of the drug
5.4 failure to adequately inform the buyer on
available product that meet on the prescriptions
5.5 Failure to indicate the generic name/
official name designated by BFAD and other
required information on the drug outlet’s label of
dispensed drugs.
5.6 failure to record or keep the prescription
filled.
5.7 failure to report to the nearest DOH
office cases of violatiove, erroneous and /or
wrong prescriptions within three (3) months
after receipt of such prescription.
Section 6. Reporting and Monitoring of Non-
Compliance.
Any interested party may report any violation of
this rules and regulations in the nearest DOH office.
Section 7. Administrative Violation
7.1. Suspension or revocation of the LTO the drug
outlet by Secretary of Health.
7.2 Professionals directly involved in the
violations shall be recommended by Secretary of Health
for appropriate administrative sanctions by PRC.

(Sqd) ALFREDO R.A BENGZON


Scecretary
REPORTERS:
 MANTAWIL, JULBAI
 MARCOLETA, HENIE JANE
 MARGATE, MAYLENE JOY
 MANGAMBIT, ALADDIN

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