AO 63 S 1989 (Read Sec 3.2)
AO 63 S 1989 (Read Sec 3.2)
AO 63 S 1989 (Read Sec 3.2)
Department of Health
OFFICE OF THE SECRETARY
Manila
March 13, 1989
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 R.A. 6675 known as
Generics Act of 1988, and the pertinent provisions of R.A. 3720 known as Food, Drugs
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 rules and
regulations are hereby promulgated.
SECTION 1
Definition of Terms
1.1
1.2
1.3
1.4
Section 2
Section 3.
3.1.2.
Hospital Pharmacies
Recognizing the special needs and circumstances of
hospitals, the following modified rules and regulations shall
govern generic dispensing in hospital pharmacies, in the
case of in-patients only:
the pharmacist shall place legibly on the required drug outlet's label
the following information:
1.
2.
3.
4.
5.
6.
7.
8.
Section 4
SECTION 5
SECTION 7
Administrative Sanctions
For violation of these Rules and Regulations, the following sanctions,
after due notice and summary hearing, may be imposed:
7.1. Suspension, or revocation of the license to operate the drug outlet by
the Secretary of Health.
7.2.
SECTION 8
Criminal Liability
The imposition of the above sanctions does not preclude the institution of
appropriate criminal proceedings pursuant to Section 12 of RA 6675
known as the Generics Act of 1988, RA 3720 known as "Foods, Drugs
and Devices and Cosmetics Act" as amended and R.A. 5921 known as
"Pharmacy Law" as amended, R.A. 6425 known as the Dangerous Drugs
Act of 1972 as amended and other relevant laws, by the regional health
office concerned, upon receipt of complaints or reports of violations.
SECTION 9
Timetable of Implementation
In order to give all affected parties adequate time for learning and
adjustment, the implementation of these Rules and Regulations shall be
in three phases, as follows:
Phase I Education Drive and Information Dissemination
This phase shall be from the date of the effectivity of these
Rules and Regulations to May 31, 1989. During this period, the
DOH, in cooperation with the Department of Education, Culture
and Sports, the Department of Local Government, and the
Philippine Information Agency, shall undertake an education
drive and information dissemination concerning the provisions of
these Rules and Regulations as well as the Generics Act of
1988.
Separability Clause
Repealing Clause
Effectivity
This order shall take effect fifteen days after its publication in two newspapers of
general circulation.