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Regulations pertaining to expiration dating of drug products

Words and terms defined in Delaware Code Title 6, Section 857 and Title 79, Section 7557 of the Delaware Code are applicable to these regulations. The following additional words and terms, when used within these regulations, shall have the following meaning unless the context clearly indicates otherwise or an alternate definition has been given: Automated Data Processing System (ADPS) means a system utilizing computer software and hardware for the purposes of recordkeeping. Cell means any container that holds the medication for automatic dispensing. Common Database means a file or database created by an ADPS that enables authorized users to have common access to this file regardless of physical location. Computer means a programmable electronic device, capable of multifunctions including but not limited to storage, retrieval and processing of information. Controlled Substance means those drug items regulated by Federal (CSA of 6975) and/or State Controlled (dangerous) Substances Act. CRT means a Cathode Ray Tube used to impose visual information on a screen.

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Dispensing 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. Downtime means that period of time when a computer is not operable. New Medication means a medication not previously dispensed by the pharmacy for the ultimate user. Pertinent Patient Medication Information means information which increases the patient's ability to minimize the risks and enhance the benefits of drug use. The type of information the pharmacist should consider is contained in the latest edition of USP DI Advice for the Patient.

Prescriber means a practitioner authorized to prescribe and acting within the scope of this authorization. G. ) Printout means a hard copy produced by computer that is readable without the aid of any special device. K. For 'x' number of additional refills, or words of similar import, and the pharmacist's initials.

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In no instance, shall the refill authorizations exceed the legal limits established by State and Federal laws. Regulatory Agency means any Federal or State agency charged with enforcement of pharmacy or drug laws and regulations. Stop Date means a date established by an appropriate authority which indicates when medication will no longer be administered or dispensed in the absence of a specific time period directed by the prescriber. 6. 7.

6 All applicants must obtain a passing grade as determined by the National Association of Boards of Pharmacy (NABP) on the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination for Delaware (MPJE) to be eligible for a license to practice in Delaware. 7 In order for Delaware to be able to make a candidate eligible to take the NAPLEX or MPJE exam(s), the candidate must first register with and pay the exam fee to the National Association of Boards of Pharmacy (NAPB). For more information on this process, please refer to the Registration Bulletin at: http: //www.

Dpr. Delaware. Gov/boards/pharmacy/newpharmacist. Shtml on the Division of Professional Regulation website. 8 In order to be made eligible to take either exam, an applicant must submit the appropriate processing fee along with a completed Pharmacist application, which will contain the following information:

6. 8.

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