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Administrative Order 64 s.

1989
Prepared by: Norman Jake C. Mabalot RPh.

A.O 64 s. 1989
Amendments of A.O No. 55 s. 1988
otherwise known as Requirements for
Labelling Materials of Pharmaceutical
Products

1. Caution on prescription drugs


A.O 55 s. 1988

2.1.15. (For Rx products)


Foods, drugs and devices
and Cosmetic Act prohibits
dispensing without
prescription

A.O. 64 s. 1989
2.1.15.1-2 For any product
belonging to List A/B: Foods,
Drugs, Devices and Cosmetics
Act prohibits dispensing without
prescription (List A/B)
2.1.15.3For all other
prescription drugs products:
Foods, Drugs, Devices and
Cosmetics Act prohibits
dispensing with out prescription

16% dispensing error - 2nd Cause of Medication Error in


Southeast
Asia. -Salmansi et. al. 2015 NCBI

2. Labels for product containing 2 or more


active ingredients
A.0. 55
s. 1988
A.O.
64 s.(LABELLING)
1989

Section 3.1.4
2 active
ingredient==11generic
or 2 generic
of box
the active ingredient
1 or
1 active
ingredient
namename
in the
boxactive ingredients = generic name will be determined
inside
2 orthe
more
by
Section
3.1.5
the FDA
3 or more active ingredient = generic name will be determined by the
FDA
A.O. 62 s. 1989 (PRESCRIBING)
Section 3.1.1
1 active ingredient = generic name of the active ingredient in the
prescription
Section 3.1.2
2 or more active ingredient = generic name as determined by the FDA

3. Labels for products in a strip or


blister pack
A.O. 55 s. 1988

10.2. For products


contained in strip or blister
packs, strength, and expiry
date must appear for
every two units..

10.2 strength, expiry


A.O.
64company
s.1989 name and
date,
batch numbers must
appear for every standard
strip.

Minimum requirements for ASEAN Harmonization


2012

Do little things now; so shall big things


come to thee.. Persian proverb
References
O. Limuaco Pharmaceutical Jurisprudence
and Ethics
http://
www.ncbi.nlm.nih.gov/pubmed/26340679
FDA.gov.ph
ASEAN guidelines on labelling requirements
for traditional medicines and health
supplements 2012