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(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. (4) Recorded and maintained in such manner that the stability data may be utilized in establishing product expiration dates. (2) Expiration dates shall be related to appropriate storage conditions stated on the labeling wherever the expiration date appears. PART B (CANCELLATION FEES THAT WILL BE INCURRED IF A HEARING AID IS RETURNED UNDER THE 30-DAY MONEY BACK GUARANTEE BELOW), WAS COMPLETED AND EXPLAINED AFTER SERVICES WERE PROVIDED AND BEFORE ANY PAYMENT WAS MADE. (3) Determined on any dry drug product that is to be reconstituted at the time of dispensing, as directed in its labeling, as well as on the reconstituted product. (1) Expiration dates appearing on the drug labeling shall be justified by readily available data from stability studies such as described in § 25.21 (relating to stability). This shall be in 10 point type or larger, and may be made out on more than one sheet of paper, but shall employ the following format or be on a form approved by the Department: (date), BEFORE ANY SERVICES WERE PROVIDED. (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. Such products shall not be marketed if intended for use in man or animals and the product is contaminated with an amount of penicillin equivalent to 0.05 unit or more of penicillin G per maximum single dose recommended in the labeling of a drug intended for parenteral administration or an amount of penicillin equivalent to 0.5 unit or more of penicillin G per maximum single dose recommended in the labeling of a drug intended for oral use. The registrant may rely on a representation by the physician, audiologist or fitter who performed or supervised the tests that the individual who performed the tests was authorized to do so. (3) Calibration shall be performed by a qualified individual other than the owner. The receipt may be made out on more than one sheet of paper and shall contain the following: (1) The date of sale.
(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 apprentices certificate of registration.
(3) The establishment of master records, when needed, containing specifications and a description of sampling and testing procedures for in-process drug preparations. The registrant shall obtain a duplicate certificate upon the loss of an original certificate or for a branch office.
(2) A reserve sample of all active ingredients as required by § 25.14 (8) (relating to components). Instead of paying the full 0 when making the application, the applicant may pay when making the initial application, and 0 before taking the examination for the first time. (f) For an apprentice fitters registration certificate, the fee is plus an additional 0 before the apprentice takes the fitters examination. (g) For a duplicate or replacement registration certificate, the fee is .
(5) Adequate provisions for checking the identity and strength of drug products for all active ingredients and for assuring: (i) Sterility of drugs purported to be sterile and freedom from objectionable micro-organisms for those drugs which should be so by virtue of their intended use. (6) Unless specifically excepted or unless listed in another schedule, a material, compound, mixture or preparation which contains any quantity of the following substances including the salts, isomers and salts of isomers: (i) Fenethylline. (a) A registrant shall display the dealers or fitters registration certificate at the place of business listed in the registrants application.
Such samples shall be adequately representative and properly identified. (5) 4-Bromo-2, 5 Dimethoxyamphetamine (4-Bromo, 2, 5 DMA) (added October 17, 1975). (i) A delinquency fee will be assessed if an applicant applies for renewal of a registration certificate after May 15. (j) For renewal of a suspended registration certificate, the fee is 0 plus the delinquency fee if one has otherwise accrued.