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(iii) Minimal contamination of ophthalmic ointments by foreign particles and harsh or abrasive substances. The registrant shall display the appropriate duplicate registration certificate in each office.

(ii) The absence of pyrogens for those drugs purporting to be pyrogen-free. (b) If a registrant maintains more than one place of business within this Commonwealth, the registrant shall apply for a duplicate registration certificate for each branch office.

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All excess package labeling bearing lot or control numbers shall be destroyed. Every pharmacy shall, at the end of each month, on forms issued for this purpose by the Office of the Attorney General of the Commonwealth, provide the Office of the Attorney General of the Commonwealth with the name of each person to whom a drug or preparation, which is classified by the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U. (2) The temporary registrant shall take the hearing aid fitter’s examination to qualify for a regular hearing aid fitter’s registration certificate. (c) The passing grade on an examination will be determined by the Secretary.

Said record shall identify the labeling and the quantities issued and used and shall reasonably reconcile any discrepancy between the quantity of drug finished and the quantities of labeling issued. (2) Upon presentation of proper billing to the Department. (4) A sponsor desiring to terminate responsibilities with regard to an apprentice shall give the apprentice 10 days written notice of the reasons for the action and shall notify the Department at the same time by certified mail. Temporary registration shall conform to the following: (1) A temporary fitter’s registration certificate will be issued to an applicant who satisfactorily demonstrates having been engaged in the fitting and selling of hearing aids at an established place of business in a state other than this Commonwealth for 2 years within a 5-year period immediately before making application and who otherwise fulfills the requirements of the act and this subchapter. (b) The date of an examination may be obtained by writing to the Division at the address given in § 25.204(a) (relating to application for and renewal of registration), by checking the Department’s website at or by phone or e-mail to the Division.

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.

Laboratory controls shall include the following: (1) The establishment of master records containing appropriate specifications for the acceptance of each lot of drug components, product containers, and their components used in drug production and packaging and a description of the sampling and testing procedures used for them. (c) For a hearing aid fitter’s registration certificate, the initial registration fee is $200, $150 of which will be refunded if the applicant is ineligible to take the qualifying fitter’s examination. (d) For a registration certificate by endorsement the fees shall be the same as in subsection (b).

Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, and test procedures to assure that components, in-process drugs, and finished products conform to appropriate standards of identity, strength, quality, and purity. Since the legislature obviously believes that the license already held by physicians and audiologists is adequate proof of their competence to fit patients with hearing aids, they are not required to take a qualifying examination prior to obtaining a hearing aid dealers certificate. The annual renewal fee is 0 for both dealers and fitters. (10) Provision that firms which manufacture non penicillin products, including certifiable antibiotic products, on the same premises or use the same equipment as that used for manufacturing penicillin products, or that operate under any circumstances that may reasonably be regarded as conducive to contamination of other drugs by penicillin, shall test such non penicillin products to determine whether any have become cross-contaminated by penicillin. The registrant shall verify that the tests were performed by an individual authorized by law to do so. (2) Instruments transported to test sites shall be calibrated to the standard set forth in paragraph (1) every 6 months, or more frequently as needed. Upon the sale of a hearing aid, the registrant shall provide the purchaser a signed receipt. They shall be identified and appropriate records maintained to determine the history of use. The registrant shall sell a hearing aid replacing another of the same make, model and response only if within 12 months before the sale an examination of the prospective hearing aid user was conducted using pure tone air conduction, bone conduction and speech audiometry tests. (6) Adequate provision for auditing the reliability, accuracy, precision, and performance of laboratory test procedures and laboratory instruments used. An office which is part of a building normally used as a residence shall be in a space set aside for office purposes only. (iv) That the drug release pattern of sustained release products is tested by laboratory methods to assure conformance to the release specifications. (c) The place of business identified in a registrant’s application shall be an office at a fixed location. (a) Finished goods warehouse control and distribution procedures shall include a system by which the distribution of each lot of drug can be readily determined to facilitate its recall if necessary. (2) The registrant shall: (i) Perform air conduction tests for hearing level thresholds at frequencies of 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz and 6,000 Hz or 8,000 Hz, with masking if necessary. (4) A signed certificate identifying the most recent date of calibration shall be maintained for inspection by the Department. (2) The make, model and serial number or, if no serial number is applicable, an identification number of the hearing aid.

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