Art. 29. Adulterated Drugs and Devices. - A drug or device shall be
deemed to be adulterated:
(a) (1) if it contains in whole or in part of any filthy, putrid, or decomposed substance which may
affect its safety, efficacy or good quality; or (2) if it has been manufactured, prepared or held under unsanitary conditions
whereby it may have been contaminated with dirt or filth or whereby it may have been rendered injurious to health; or (3)
if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents
injurious to health; or (4) if it bears or contains any color other than a permissible one as determined by the Department,
taking into consideration standards of safety, efficacy or good quality.
(b) If it purports to be or is represented as a drug,
the name of which is recognized in an official compendium, and its strength differs from, or its safety, efficacy, quality
or purity falls below the standards set forth in such compendium, except that whenever tests or methods of assay as prescribed
are, in the judgment of the Department, insufficient for the making of such determination, the Department shall promulgate
regulations prescribing appropriate tests or methods of safety, efficacy, quality or purity shall be made. No drug defined
in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standards of
strength, safety, efficacy, quality or purity therefor set forth in such compendium, if its difference in strength, safety,
efficacy, quality or purity from such standards is plainly stated in its label and approved for registration as such.
(c) If it is not
subject to the provisions of paragraph (b) and its strength differs from, or its efficacy, quality or purity falls below,
that which it purports or is represented to possess.
(d) If a drug or device and any substance has been mixed
or packed therewith, or any substance has been substituted wholly or in part thereof, so as to reduce its safety, efficacy,
quality, strength or purity.
(e) If the methods used in, or the facilities or controls used for its manufacture or holding do not
conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such
drug meets the requirements of this Act as to safety, quality and efficacy, and has the identity and strength, and meets the
quality and purity characteristics which it purports or is represented to possess.
Art. 30. Exemption in Case of Drugs
and Devices. - (a) The Department is hereby directed to promulgate regulations exempting from any labeling or packaging
requirement of this Act drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled
or repacked in substantial quantities at establishments other than those where originally processes or packed, on conditions
that such 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:
are habit-forming; 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.
(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;
(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. chanrobles law
(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.
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.
Art. 31. Licensing and Registration.
- (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.
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.
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.
(h) No drug or device shall be manufactured, sold, offered for sale, imported, exported,
distributed or transferred, unless registered by the manufacturer, imported or distributor thereof, in accordance with rules
and regulations promulgated by the Department pursuant to this Act. The provisions of Article 31 (b), (d) and (e), to the
extent applicable, shall govern the registration of such drugs and devices.
(i) The Department shall promulgate a schedule of fees for the issuance of the certificate
of product registration and license to operate provided for under this Article.
Art. 32. Dangerous Drugs. - The importation, distribution,
manufacture, production, compounding, prescription, dispensing and sale of, and other lawful acts in connection with, dangerous
drugs of such kind and quantity as may be deemed necessary according to the medical and research needs of the country and
the determination of the quantity/quantities to be imported, manufactured and held in stock at any given time by an authorized
importer, manufacturer or distributor of dangerous drugs shall be under the jurisdiction and authority of the Dangerous Drugs
Board as provided for by existing laws and regulations.
Art. 33. Banned or Restricted Drugs. - Banned or severely
restricted drugs for health and safety reasons in their country of origin shall be banned and confiscated or its uses severely
restricted whichever is appropriate, by the Department. The Department shall monitor the presence in the market of such drugs
and cause the maintenance and regular publications of an updated consolidated list thereof.