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.
Article 32. Dangerous Drugs. โ 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.
Article 33. Banned or Restricted Drugs. โ 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.
CERTIFICATION OF DRUGS CONTAINING ANTIBIOTICS
Article 34. Certification of Certain Drugs. โ
a) The Department shall, by regulations, provide for the certification of batches of drugs composed wholly or partially of any
kind of antibiotic. A batch of such drug shall be certified if such drug has such characteristics of identity, strength, quality
and purity, as the Department prescribes in such regulations as necessary to insure adequately safety and efficacy of use
and good quality, but shall not otherwise be certified. Prior to the effective date of such regulations the Department, in lieu
of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and
efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to
be effective as to such batch and as to portions thereof. For purposes of this Article and of Article 89 (j), the term "antibiotic
drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a
micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including the chemically
synthesized equivalent of any such substance).
b) Whenever in the judgment of the Department, the requirements of this Article and of Article 89 (j) with respect to any
drug or class of drugs are not necessary to insure safety and efficacy of use and good quality, the Department shall
promulgate regulations exempting such drug or class of drugs from such requirements.
c) The Department shall promulgate regulations exempting from any requirement of this Article and of Article 89 (j), (l)
drugs which are to be stored, processed, labeled, or repacked at establishments other than those where manufactured, or
condition that such drugs comply with all such requirements upon removal from such establishments; (2) drugs which
conform to applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended
for use in manufacturing other drugs; and (3) drugs which are intended for investigational use by experts qualified by
scientific training and experience to investigate the safety and efficacy of drugs.
COSMETICS
Article 35. Adulterated cosmetics. โ A cosmetic shall be deemed to be adulterated:
a) if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the condition
of use prescribed in the labeling thereof, or under the condition of use as are customary or usual: Provided, That this
provision shall not apply to color additive hair dye, the label of which bears the following legend conspicuously displayed
thereon: "Caution: this product contains ingredients which may cause skin irritation on certain individuals and a preliminary
test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or
eyebrows; to do so may cause blindness" and labeling of which bears adequate directions for such preliminary testing. For
purposes of this paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes.
b) if it consists in whole or in part of any filthy, putrid, or decomposed substance.
c) if it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth,
or whereby it may have been rendered injurious to health.
d) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the
contents injurious to health.
e) if it is not a hair dye, and it bears or contains color additive other than which is permissible.
f) if any of its substances has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted
wholly or in parts therefor.
Article 36. Factory Inspection. โ
a) For purposes of enforcement of this Article, officers or employees duly designated by the Department, upon presenting
appropriate credentials to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable hours, any
factory, warehouse or establishment in which food, drugs, devices or cosmetics are manufactured, processed, packed or
held, for introduction into domestic commerce or are held after such introduction, or to enter any vehicle being used to
transport or hold such food, drugs, devices, or cosmetics in domestic commerce; and (2) to inspect, in a reasonable
manner, such factory, warehouse, or establishment or vehicle and all pertinent equipment, finished and unfinished
materials, containers and labeling therein.
b) If the officer or employee making any such inspection of a factory, warehouse or other establishment has obtained any
sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to
the owner, operator, or agent in charge a receipt describing the samples obtained.
