drugs and devices are not adulterated or mislabeled under the provisions of this Act upon removal from such processing,
labeling or repacking establishment.
b) 1) Drugs intended for use by man which:
(i) are habit-forming;
(ii) because of their toxicity or other potentiality for harmful effect, or method of their use is not safe for use
except under the supervision of practitioner licensed by law to administer such drug;
(iii) are new drugs whose applications are limited to investigational use; shall be dispensed only (a) upon written
prescription of a practitioner licensed by law to administer such drug, or (b) upon an oral prescription of such
practitioner which is reduced promptly to writing and filed by the pharmacist, or (c) by refilling any such written
or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral
order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to
the provisions of this paragraph shall be deemed to be an act which results in the drug being mislabeled while
held for sale.
2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer such drug
shall be exempt from the requirements of Article 89, except paragraphs (a), (h), (2) and (3), and the packaging
requirements of paragraphs (f) and (g), if the drug bears a label containing the name and address of the dispenser, the
serial number and the date of the prescription or its filling, the name of the prescriber and, if stated in the prescription the
name of the patient and the directions for use and cautionary statements, if any, container in such prescription.
3) The Department may, by regulation, remove drugs subject to Article 89 (d) and Article 31 from the requirements of sub-
article (b) (1) of this Article, when such requirements are not necessary for the protection of the public health.
4) A drug which is subject to sub-article (b) (1) of this Article shall be deemed to be mislabeled if any time prior to
dispensing, its label fails to bear the statement "Caution: Should not be dispensed without prescription." A drug to which
sub-article (b) (1) of this Article does not apply shall de deemed to be mislabeled it at any time prior to dispensing, its label
bears the caution statement quoted in the preceding sentence.
Article 31. Licensing and Registration. โ
a) No person shall manufacture, sell, offer for sale, import, export, distribute or transfer any drug or device, unless an
application filed pursuant to sub-article (b) hereof is effective with respect to such drug or device.
b) Any person may file with the Department, through the Department, an application under oath with respect to any drug or
device subject to the provisions of sub-article (a) hereof. Such persons shall submit to the Department: (1) full reports of
investigations which have been made to show whether or not such drug or device is safe, efficacious and of good quality
for use based on clinical studies conducted in the Philippines; (2) a full list of the articles used as components of such drug
or device; (3) a full statement of the composition of such drug or device; (4) a full description of the methods used in and
the facilities and controls used for the manufacture of such drug or device; (5) such samples of such drug or device and of
the articles used as components thereof as the Department may require; (6) specimens of the labeling proposed to be
used for such drug or device; and (7) such other requirements as may be prescribed by regulations to ensure safety,
efficacy and good quality of such drug and device.
c) Within one hundred eighty (180) days after the filing of an application under this sub-article, or such additional period as
may be agreed upon by the Department and the applicant, the Department shall either (1) approve the application if he
then finds that none of the grounds for denying approval specified in sub-article (d) applies, or (2) give the applicant notice
of an opportunity for a hearing before the Department under sub-article (d) on the question whether such application is
approvable.
d) If the Department finds, after due notice to the applicant and giving him an opportunity for a hearing, that (1) the reports
of the investigations which are required to be submitted to the Department pursuant to sub-article (b) hereof, do not include
adequate tests by all methods reasonably applicable to show whether or not such drug or device is safe, efficacious and of
good quality for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof; (2) the
results of such test show that drug or device is unsafe, inefficacious or of doubtful therapeutic value for use under such
conditions or do not show that such drug or device is safe, methods used in, and the facilities and controls used for the
manufacture of such drug or device are inadequate to preserve its identity, strength, quality and purity; or (4) upon the
basis of the information submitted to him as part of the application, or upon the basis of any other information before him
with respect to such drug or device, he has insufficient information to determine whether such drug or device is safe,
efficacious or of good equality for use under such conditions; or (5) evaluated on the basis of the information submitted to
him as part of the application, and any other information before him with respect to such drug or device, there is a lack of
substantial evidence that the drug or device will have the effect it purports or is represented to have under the conditions of
use prescribed, recommended or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all
material facts, such labeling is false or misleading in any way; he shall issue an order disapproving the application.
e) The effectiveness of an application with respect to any drug or device shall, after due notice and opportunity for hearing
to the applicant, by order of the Department be suspended if it finds (1) that clinical experience, tests by new methods, or
tests by methods not deemed reasonably applicable when such application became effective show that such drug or
device is unsafe or ineffective for use under the conditions of use upon the basis of which the application became effective,
or (2) that the application contains any untrue statement of a material fact. The order shall state the findings upon which it
is based.
f) The Department shall promulgate regulations for exempting from the operation of this Article drugs and devices intended
solely for investigational used by experts qualified by scientific training and experience to investigate the safety and
effectiveness of drugs and devices.
g) No person shall manufacture, sell, offer for sale, import, export, distribute or transfer any drug or device without first
securing a license to operate from the Department after due compliance with technical requirements in accordance with the
rules and regulations promulgated by the Department pursuant to this Act.
