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Consumer Act of the PHILIPPINES

CERTIFICATION OF DRUGS CONTAINING ANTIBIOTICS

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GENERAL PROVISIONS
CHAPTER 1CONSUMER PRODUCT QUALITY AND SAFETY
Chapter 2 FOODS, DRUGS, COSMETICS AND DEVICES
DRUGS AND DEVICES
CERTIFICATION OF DRUGS CONTAINING ANTIBIOTICS
COSMETICS
Chapter 3 HAZARDOUS SUBSTANCE
TITLE III PROTECTION AGAINST DECEPTIVE, UNFAIR AND UNCONSCIONABLE SALES ACTS OR PRACTICES
REGULATION OF SALES ACTS AND PRACTICES
CHAPTER II REGULATION OF PRACTICES RELATIVE TO
CHAPTER IIICONSUMER PRODUCT AND SERVICE WARRANTIES
CHAPTER IV LABELING AND FAIR PACKAGING
CHAPTER V LIABILITY FOR PRODUCT AND SERVICE
CHAPTER VI ADVERTISING AND SALES PROMOTION
CHAPTER VII REGULATION OF REPAIR AND SERVICE FIRMS
TITLE IV CONSUMER CREDIT TRANSACTION
TITLE V THE NATIONAL CONSUMER AFFAIRS COUNCIL
CHAPTER II POWERS AND FUNCTIONS
CHAPTER III CONSUMER COMPLAINTS
TITLE VI TRANSITORY AND FINAL PROVISIONS
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Art. 34. Certification of Certain Drugs. - (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.

 

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