What are the specific requirements for compounding

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Reference no: EM132288802

Pharmacy Law Individual State Assignment

Assignment:

This assignment is designed to test your research skills and to highlight certain important issues seen in state pharmacy laws. Most of these questions come di-rectly from the MPJE competency statements.

Pick any one state except for Florida to research. Answer 7 out of the first 9 questions listed, as well as question 10, about that state. (NOTE: everyone must answer number 10.) Provide references and links to statutes or regulations in each answer. Please summarize / outline your answers and employ proper grammar and spelling in your answers. DO NOT SIMPLY CUT AND PASTE.

To help illustrate how to answer the questions, an answer for Pennsylvania has been provided below. (If you select PA as your state, this will count as one of the questions you do not have to answer). Delete the answer for PA below and re-place with your answers for the state you select.

Do not leave any of the ques-tions blank. For the 2 questions you do not select, leave them typed on the document and place the comment "did not select this question". Provide an explanation if there is no information or answer (for example, if the state you select does not define pharmacy practice specifically, explain that and how you got to that determination).

Submit your NEAT, PROFESSIONAL, completed assignment, by the due date/time. For grading, the following will be considered for each question: *was the question properly answered? *was the question completely answered? *was the question properly referenced? *was the question neatly summarized/outlined using proper grammar?

1. What practice activities are permitted or defined for the practice of pharmacy in the state selected?

MODEL ANSWER: In Pennsylvania, the Pharmacy Act and Board Regulations allow/define the following activities within the practice of pharmacy: the interpretation, evaluation and implementation of medi-cal orders for the provision of pharmacy services or prescription drug orders; the delivery, dispensing or distribution of prescription drugs; participation in drug and device selection; drug administration; drug regimen review; drug or drug-related research; compounding, proper and safe storage of drugs and devices, managing drug therapy in an institutional setting consistent with the institution's assignment of clinical duties; maintaining proper records; patient counseling; acts, services, operations or transactions necessary or incident to the provision of these health care services. Also, the law and rules state that the practice of pharmacy does not include operations of a manufacturer or distributor.

References:

1. Pennsylvania Pharmacy Act, 63 P.S. Section 390(2)(11)

2. Pennsylvania State Board of Pharmacy Rules and Regulations, 49 PA Code Chapter 27, Section 27.1

2. In the state selected, may a pharmacist dispense an emergency prescrip-tion refill? What are the requirements that must be met to do this? (This typical scenario includes a patient running out of their blood pressure medication on a Friday evening and the prescriber is not available to reach for a refill)

3. What are the qualifications, scope of duties, and conditions for practice relating to pharmacy technicians and all other non-pharmacist personnel, including personnel ratios, duties, tasks, roles, and functions of non-pharmacist personnel?

4. What is the scope of authority and scope of practice of mid-level practi-tioners who are authorized under state law to prescribe? Address pre-scribing in general, but also do not forget to include within your answer restrictions or limits on controlled substances.

5. What are the conditions under which the pharmacist participates in the administration of pharmaceutical products, and/or in the management of patients' drug therapy?

6. What are the requirements for the transfer of existing prescription/order information from one pharmacist to another? (Include noncontrolled substances and controlled substances)

7. What are the specific requirements for compounding pharmaceutical products in the state selected?

8. What are the conditions regarding the return and/or reuse of pharma-ceutical products, preparations, bulk drug substances/excipients, and devices. Charitable programs, cancer or other repository programs, pre-viously dispensed, and from ""will call"" areas of pharmacies?

9. What are the requirements for reporting to PMP and accessing informa-tion in a PMP?

10. (EVERY STUDENT MUST ANSWER THIS QUESTION) What are the special requirements for the issuance of controlled substance prescriptions/drug orders, including content and format for written; telephonic voice transmission; electronic facsimile; computerized and Internet; during emergency conditions; conditions for changing a prescription; time limits for dispensing initial prescriptions/drug orders; and requirements for multiple Schedule II prescription orders?

Reference no: EM132288802

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