§ 431.11 - Conditions on the effectiveness of certificates.

(a) A certificate shall not become effective:

(1) If it is obtained through fraud or through misrepresentation or concealment of a material fact;

(2) With respect to any package unless it complies with the packaging requirements, if any, prescribed by the regulations in this chapter which were in effect on the date of the certificate;

(3) With respect to any package unless its label and labeling bear all words, statements, and other information required by the regulations in this chapter; or

(4) With respect to any package of a certifiable antibiotic drug subject to the regulations in this chapter, when it is included in a packaged combination with another drug, unless such other drug complies with the requirements of the regulations in this chapter.

(b) A certificate shall cease to be effective:

(1) With respect to any immediate container after the expiration date, if any, prescribed by the regulations in this chapter;

(2) With respect to any immediate container when it or its seal (if the regulations in this chapter require it to be sealed) is broken, or when its label or labeling is altered, multilated, destroyed, obliterated, or removed in whole or in part, or ceases to conform to any labeling requirement prescribed by the regulations in this chapter, except that:

(i) If the drug in such container is repacked or used as an ingredient in the manufacture of another drug, and certification of the batch thus made is requested, such certificate shall continue to be effective for a reasonable time to permit certification or destruction of such batch;

(ii) If the drug is in a container packaged for dispensing and is used in compounding a prescription issued by a practitioner licensed by law to administer such drug, such certificate shall continue to be effective for a reasonable time to permit the delivery of the drug compounded on such prescription; or

(iii) If its label or labeling is removed in whole or in part for the purpose of relabeling and supplemental certification of the relabeled drug is requested, as provided by § 433.12 of this chapter.

(3) With respect to any immediate container of penicillin when it is included in the packaged combination penicillin with aluminum hydroxide gel or penicillin with a vasoconstrictor, or to any immediate container of bacitracin when it is included in the packaged combination bacitracin with a vasoconstrictor, except that when certification of the batch so included is requested, such certificate shall continue to be effective for a reasonable time to permit certification of such batch which is part of such combination;

(4) With respect to any package when the drug therein fails to meet the standards of identity, strength, quality, and purity which were in effect on the date of the certificate; except that those minor changes which occur before the expiration date and which are normal and unavoidable in good storage and distribution practice shall be disregarded.

(5) With respect to any package of a certifiable antibiotic drug subject to the regulations in this chapter, included in a packaged combination with another drug, when such other drug fails to meet the requirements of the regulations in this chapter; or

(6) With respect to any immediate container, if such regulations require its labeling to bear a caution against dispensing otherwise than on prescription, at the beginning of the act of dispensing or offering to dispense it otherwise than:

(i) By a practitioner licensed by law to administer such drug; or

(ii) On his prescription issued in his professional practice.