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(5) Provide for adequate examination or laboratory testing of representative samples of finished products after packaging and labeling to safeguard against any errors in the finishing operations and to prevent distribution of any batch until all specified tests have been met. Code § 113.25 (relating to drug distribution systems). The temporary registrant shall take the qualifying examination no earlier than 90 days after the date the temporary registration certificate was issued, and no later than 1 year after the date the temporary registration certificate was issued. (b) For a hearing aid dealer, the initial registration fee is 0 if the Department issues the registration certificate between April 15 and October 14, and 0 if the Department issues the registration certificate between October 15 and April 14.

(7) A properly identified reserve sample of the finished product (stored in the same immediate container closure system in which the drug is marketed) consisting of at least twice the quanitity necessary to perform all the required tests, except those for sterility and determination of the absence of pyrogens, and stored under conditions consistent with product labeling shall be retained for at least 2 years after the drug distribution has been completed or at least 1 year after the drug’s expiration date, whichever is longer. (d) A registrant shall file notice of a change in the registrant’s place of business with the Department at least 10 work days before the change by writing to the Department at the address given in § 25.204(a) (relating to application for and renewal of registration). Such records shall also provide for appropriate retesting of drug components, product containers, and their components subject to deterioration. A refund of the 0 will be made if the applicant is ineligible to take the qualifying examination for a fitter’s registration certificate. Said samples shall be representative and adequately identified. (e) For a temporary hearing aid fitter’s registration certificate, the initial registration fee is 0, 0 of which is for the examination. Such issue shall be carefully checked by a competent and responsible person for identity and conformity to the labeling specified in the batch production record. Compensation for the samples taken pursuant to the provisions of the act shall be made under the following conditions: (1) When the samples are found to be in compliance with the provisions of the act. § 3801 and the act as a controlled substance in Schedule II, was sold, dispensed, distributed or given away, except when used in anesthetic procedures, together with such other information as may be required, under the act. An affirmed statement may be given in any form so long as it is in writing, signed, and contains a statement to the effect that it is truthful. (a) An examination to obtain registration as a hearing aid fitter shall be held at least twice each year, at a time and place to be fixed by the Secretary at least 45 days before the examination date. (4) Provide strict control of the package labeling issued for use with the drug. (6) That part of any official sample which is in excess of three times the quantity it estimates to be sufficient for analysis. (3) An apprentice hearing aid fitter desiring to change sponsors shall furnish the Department a sworn or affirmed request giving reasons for the change and a sworn or affirmed statement from the new sponsor setting forth the information required by paragraph (2), and accompanied by the apprentice’s certificate of registration.

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