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Drug expiration dating calculations

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"" means the art of the extemporaneous preparation and manipulation of drugs as a result of a practitioner's prescription order or initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice, including the preparation of drugs in anticipation of drug orders based on routine, regularly observed prescribing patterns."" means to furnish or deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner; including the preparation, packaging, labeling or compounding necessary to prepare the drug for that delivery.The quality control and testing for CSPs in this chapter are appropriate and necessary.The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed.This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.Active Pharmaceutical Ingredients (API) and intermediates for pharmaceutical use (i.e.

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Greater care is required for aqueous injections that are compounded sterile preparations (CSPs)—the most common CSPs used in therapy.pharmaceutical, radiopharmaceutical, and biological) and those used to manufacture drugs for clinical trials are regulated under the Divisions 1A and 2, Part C of the guidelines, GUI-0104, are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements.It should be noted that these guidelines do not cover safety aspects for the personnel engaged in the fabrication, packaging/labelling, and testing of APIs and intermediates, or aspects of protection of the environment.Please click the following link to see the details on our Product Dating Information.Dexamethasone solutions are stable for 6 months when aliquoted stored at -20 °C in a non-defrosting freezer and protected from light.Frequently Asked Questions are available for this Product.