Professional Documents
Culture Documents
Department of Health
OFFICE OF THE SECRETARY
Manila
March 9, 1989
ADMINISTRATIVE ORDER
No. 62 s. 1989
SUBJECT:
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 and R.A. 4224 and R.A. 5946; R.A. 4419 known as the
Dental Act, R.A. 382 known as the Veterinary Act, and R.A. 6425 known as the
Dangerous Drug 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
1.5
1.6
Drugs means (1) articles recognized in the current official United States
Pharmacopoeia-National Drug Formulary (USP-NF), official Homeopathic
Pharmacopoeia of the United States, Official Philippine National Drug
Formulary, or any supplement to any of them, and (2) articles intended
for use to diagnosis, cure, mitigation, treatment or prevention of disease
in man or animals; and (3) articles (other than food) intended to affect the
structure or function of the body of man or animals; and (4) articles
intended for use as a component of any articles specified in clauses (1),
(2) or (3) but do not include devices or their components, parts or
accessories.
1.7
Drug product or medicine is the finished form that contains the active
ingredient(s), generally, but not necessarily in association with inactive
ingredients.
1.8
1.7.1
1.7.2
1.8.2
1.9
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:
3.1.2.1. Upon admission, the patient or his/her responsible
relative shall indicate in writing whether he/she shall
submit to the hospital drug policies or reserve the
option to buy drugs and medicines outside of the
hospital pharmacy.
3.1.2.2. Hospital pharmacies operating on an acceptable
formulary system and pricing policy as determined
by the Department of Health (DOH), and using
generic terminology in procurement, prescribing,
dispensing, and recording of drugs, shall be
exempted from the following:
3.1.2.3. Recording of prescriptions filled in the
prescription
book,
provided
such
prescription
book,
provided
such
prescriptions shall be kept in file for two
years.
3.1.2.4. Individually informing the in-patient/buyer
on the available generic equivalents and
Section 4
3.4.1.
3.4.2.
3.4.3.
SECTION 5
SECTION 6
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.
Phase 2 Monitoring of Compliance without Sanctions or Penalties
From June 1, 1989 to August 31, 1989, the DOH shall monitor
voluntary compliance with the provisions of the Rules and
Regulations on Prescribing and Dispensing. During this period,
the associations of affected professionals are enjoined to
promote compliance in order to achieve a smooth transition to
the next phase of full implementation.
Phase 3 Full Implementation
Beginning September 1, 1989, the DOH and the other relevant
agencies of government shall monitor compliance with these
Rules and Regulations and all violations shall be subject to the
appropriate sanctions and penalties provided for under these
Rules and Regulations and the Generics Act of 1988.
SECTION 10
Separability Clause
Repealing Clause
Effectivity
This order shall take effect fifteen days after its publication in two newspapers of
general circulation.