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What is the minimum temperature range required for storage of drugs in a refrigerator?
What is the minimum height of the partition required for a pharmacy operated as a department of a general merchandising establishment?
What is the purpose of the exhaust hood and filter system in a pharmacy that dispenses radioactive drugs?
What is the minimum number of contact hours of didactic instruction required for a pharmacist to dispense radioactive drugs?
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What is the primary purpose of the laminar flow hood in a pharmacy that dispenses radioactive drugs?
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What is the minimum number of hours of clinical nuclear pharmacy training required for a pharmacist to dispense radioactive drugs?
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What is the purpose of the single-channel and/or multichannel scintillation detection system in a pharmacy that dispenses radioactive drugs?
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What is the certification required for a pharmacist to dispense radioactive drugs?
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What is the purpose of the chromatography apparatus in a pharmacy that dispenses radioactive drugs?
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What is the requirement for a pharmacy that was registered initially prior to the effective date of the paragraph on the basis of meeting requirements less than those specified?
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Under what circumstances can a pharmacist or pharmacy intern fill a prescription without violating the requirements of this subparagraph?
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Who can convey an offer to counsel the patient or person authorized to act on behalf of the patient on behalf of the pharmacist or pharmacy intern?
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Who is responsible for conducting counseling sessions?
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What must a pharmacist or pharmacy intern include with each prescription?
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What must be provided with the written offer to counsel for pharmacies engaged primarily in mail order delivery of prescriptions?
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When must a pharmacist or pharmacy intern personally counsel a patient or person authorized to act on behalf of the patient?
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What can be included in counseling sessions?
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Under what circumstances can a pharmacist or pharmacy intern refuse to dispense a prescription?
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How can counseling be conducted?
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Who can request counseling?
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What is required for a certificate of registration to be endorsed to another address?
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Within what time frame must the State Board of Pharmacy be notified of a change in officers for a corporation?
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What is the minimum notice period for an application for endorsement to a new address?
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What must registered establishments ensure regarding their premises?
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In the event of a disaster like fire or flood, how soon must the State Board of Pharmacy be notified?
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What is required to obtain or continue a certificate of registration for a pharmacy?
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Where must a sign displaying the full name of the registrant be prominently displayed?
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What does Section 63.8 of the outlined provisions specifically focus on?
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A pharmacy dispensing both radioactive and non-radioactive drugs must:
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The patient medication profile should include all of the following EXCEPT:
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A prospective drug review before dispensing a prescription includes screening for:
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When is counseling required for a patient receiving a new prescription?
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Which of the following is NOT a component of required patient counseling?
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What is the duration for which patient medication profiles must be maintained?
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Who can provide patient counseling according to the content?
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What is the main purpose of a prospective drug review?
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How can patient counseling be delivered for prescriptions dispensed off-premises?
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According to the content, what should be avoided in the counseling process?
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What is required from a pharmacist at a registered pharmacy when transferring prescription information?
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How long must a pharmacy maintain the hard copy of a transferred prescription?
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What must be included on the hard copy of the transferred prescription by the accepting pharmacist?
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Which of the following is necessary for a refill transfer to be valid?
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In order to secure registration, a pharmacy must possess which of the following utensils?
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What information must be recorded by the pharmacist who transfers original prescription information?
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Which of the following statements about automated data processing systems in pharmacies is true?
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What constitutes a valid transfer of original prescription information from one pharmacy to another?
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Which parameter must a pharmacy maintain in its registered area?
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What is the maximum number of refills that can be transferred per request?
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When dispensing a prescriber approved alternative drug, under what circumstances is the pharmacist or pharmacy intern NOT required to make a reasonable effort to contact the patient or person authorized to act on behalf of the patient by telephone to offer counseling?
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What must the pharmacist or pharmacy intern include with each prescription when dispensing a prescriber approved alternative drug?
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When is the pharmacist or pharmacy intern allowed to commence their efforts to contact the patient or person authorized to act on behalf of the patient by telephone?
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What is the minimum number of attempts the pharmacist or pharmacy intern must make to contact the patient or person authorized to act on behalf of the patient by telephone within 48 hours of mailing or delivering the prescription?
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If the patient or person authorized to act on behalf of the patient refuses to accept counseling, what action must the pharmacy take?
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Who is authorized to provide counseling to the patient or person authorized to act on behalf of the patient regarding the prescriber approved alternative drug?
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What topics must the pharmacist or pharmacy intern discuss with the patient or person authorized to act on behalf of the patient during counseling about the prescriber approved alternative drug?
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When is the pharmacist or pharmacy intern required to document their efforts to contact the patient or person authorized to act on behalf of the patient by telephone?
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What happens when the pharmacist or pharmacy intern determines that the prescription is a prescriber approved alternative drug, meaning a change in the drug originally prescribed exclusive of generic substitutions, and does not meet the requirements set forth in the text?
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When dispensing a prescriber approved alternative drug, what is the purpose of the special written notification included with the prescription?
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What is the frequency with which an outsourcing facility must submit a report to the executive secretary of the state board of pharmacy after initial registration?
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Which of the following is NOT included in the report that outsourcing facilities must submit every six months?
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What must a pharmacist or pharmacy intern do when potential drug therapy problems are identified?
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What must outsourcing facilities maintain records of for a minimum of five years?
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What must be done if the patient refuses the offer for counseling?
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In which scenario can a pharmacist refuse to dispense a prescription?
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What is the primary prerequisite for distribution or dispensing of drugs by an outsourcing facility?
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What information must registered pharmacies provide regarding their drug retail price list?
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Which regulatory document must outsourcing facilities comply with according to the requirements mentioned in the content?
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What is the fee for each certificate issued to a registered manufacturer or wholesaler?
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What is the minimum height requirement for the text on the sign notifying customers of the drug retail price list availability?
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How should pharmacies inform consumers who receive prescriptions through mail order about the drug retail price list?
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What role must be present at all times in an outsourcing facility according to the regulations?
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What is the minimum size requirement for the registered area of an establishment?
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In which circumstances can the Commissioner waive regulations related to outsourcing facilities?
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Who is authorized to personally offer counseling to the patient according to the regulations?
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What must an outsourcing facility submit during initial registration and at each renewal?
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Which of the following is NOT a requirement from the pharmacist or pharmacy intern when identifying drug therapy problems?
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Who can supervise a wholesaler that does not engage in repacking?
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Which is NOT a requirement for a supervisor of an establishment that handles compressed medical gases?
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What is the purpose of the quality control records that outsourcing facilities must maintain?
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What may a pharmacist choose to counsel regarding when identifying drug therapy problems?
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Which of the following scenarios would NOT constitute a potential drug therapy problem?
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What is the duration for which records of receipt and disposition of all drugs must be maintained?
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What type of degree is required for an individual supervising the manufacturing and repacking of compressed medical gases?
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Which supervisor is not permitted to also supervise another establishment registered by the board?
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What condition must be satisfied for manufacturers or wholesalers to sell drugs?
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What is required for a wholesaler that transfills medical oxygen regarding supervisory personnel?
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Which of the following supervisory qualifications for an outsourcing facility is incorrect?
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Which requirement related to the registered establishment's operations is NOT specified?
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Under what circumstance is a pharmacist permitted to dispense a brand-name drug instead of a generic drug, despite the prescriber's intent for a generic substitute?
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What is the minimum duration for which a pharmacy must retain an electronic prescription or a hard copy of an electronic prescription?
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Which of the following is NOT a requirement for an electronic prescription to be considered valid?
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In what instance is a pharmacist specifically required to document the date, hour, and nature of a medical emergency in the prescription record?
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Which of the following is NOT a permissible method for a prescriber to transmit a prescription to a pharmacist?
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If a pharmacy maintains an electronic prescription, how should it make the prescription available to the Department upon request?
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What does the term 'electronic signature' refer to in the context of an electronic prescription?
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Which of the following is NOT a permissible action for a pharmacist to take when accepting an electronic prescription?
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Which of the following best describes the primary objective of encrypting an electronic prescription?
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What is the main difference between a prescription transmitted by facsimile and an original hard copy prescription?
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Study Notes
General Provisions for Pharmacies in New York State
- Applies to all pharmacy establishments located in New York State.
- Registration required for nonresident establishments as outlined in Section 63.8.
- Certificates of registration are address-specific and must be endorsed by the State Board of Pharmacy for any location changes.
Certificate Regulations
- Applications for address endorsement must be submitted at least 30 days before relocation.
- Corporations must notify the Board of any officer or major stockholder changes within 30 days.
- A valid certificate requires cleaner premises equipped with proper sanitary appliances.
Damage Notification
- Any damage to a registered establishment must be reported to the Board within 48 hours.
Signage Requirements
- Signage displaying the full name of the registrant must be prominently displayed on the establishment's exterior.
Electronic Prescription Standards
- Electronic prescriptions must have an electronic signature, be encrypted, and stored securely for five years.
- Substitution of medications is allowed under specific conditions, especially during emergencies.
- A pharmacist can dispense a brand-name drug if a generic is unavailable when the price does not exceed the generic's expected cost.
Prescription Transfer Regulations
- Pharmacists can transfer prescriptions for one authorized refill, requiring direct communication between pharmacists.
- Original prescription data must be correctly recorded during transfers.
Pharmacy Equipment and Facilities
- Pharmacies must have specific measuring devices, adequate space (minimum 300 square feet), and environmental controls to store drugs safely.
- Requirements include a refrigerator maintained at 2°C to 8°C dedicated to drug storage.
Patient Medication Profiles
- Pharmacists must maintain detailed profiles for each patient, including personal information, allergies, and medication history for five years.
- A prospective drug review must occur before dispensing prescriptions to identify potential issues.
Counseling Requirements
- Face-to-face counseling is required for new patients and prescriptions, covering medication details, dosages, side effects, and storage.
- Counseling can be delegated only to licensed professionals but must be provided by a pharmacist or pharmacy intern.
- Patients refusing counseling or information will not affect prescription filling, provided documentation of refusal is kept.
Off-Premises Delivery Protocols
- Each prescription delivered off-site must include a written offer of counseling, along with a phone number to reach a pharmacist.
- Mail-order pharmacies must provide toll-free numbers for customer inquiries.
Radioactive Drugs Standards
- Pharmacies dispensing radioactive drugs must comply with specific state regulations and requirements, needing certified pharmacists present during operations.
Summary of Required Equipment
- Key equipment includes weighing devices, measuring instruments, refrigeration, and specific tools for handling radioactive drugs if applicable.### Counseling Protocol for Pharmacists
- Pharmacists or pharmacy interns must personally counsel patients or authorized representatives upon request for counseling, according to professional judgment.
- Counseling topics may cover all areas defined in specific clauses of the regulation.
- Counseling can be conducted via telephone or in-person meetings.
Prescriber Approved Alternative Drugs
- A prescriber approved alternative drug is a substitution not including generic variations.
- Upon dispensing, a written notification must be given to the patient detailing the alternative drug dispensed, usage instructions, and counseling availability.
- Pharmacists or pharmacy interns must make at least two attempts to contact the patient by telephone within 48 hours of mailing the prescription.
Documentation Requirements
- Efforts made to contact patients must be documented, including refusals to provide telephone numbers.
- If counseling is declined, this refusal must be recorded in pharmacy records.
Potential Drug Therapy Problems
- Pharmacists must contact patients if there are potential therapeutic problems such as drug-drug interactions or allergies before dispensing medications.
- Offers of counseling in such cases should also be personally provided and documented if declined.
Drug Retail Price Lists
- Registered pharmacies selling prescription medications must post a sign stating "Drug Retail Price List Available Upon Request" in noticeable locations.
- Pharmacies offering deliveries or online services must notify consumers of the price list availability with each prescription.
Manufacturer and Wholesaler Regulations
- A registered pharmacist must be present at establishments for drug manufacturing or wholesaling when open for business.
- Supervisors must have relevant education or experience qualifications, such as a degree in chemistry or pharmaceutical manufacturing.
Supervising Medical Oxygen Transfillers
- Specific qualifications are required for supervising the transfilling of medical oxygen, focusing on credentials in respiratory therapy or related fields.
Establishment Size and Compliance
- Registered establishments must measure at least 300 square feet and cannot share space with other businesses.
- Compliance with federal regulations is mandatory, including documenting drug receipt and distribution for five years.
Outsourcing Facility Regulations
- Outsourcing facilities must periodically report compounded drugs to the state board, detailing active ingredients and production specifics.
- They must maintain quality control records for five years and adhere to current good manufacturing practices.
Registration and Compliance for Outsourcing Facilities
- Registration as an outsourcing facility requires regular documentation to confirm compliance with federal regulations.
- Inspections must be reported, and facilities must not dispense drugs unless registered as a pharmacy in New York State.
Waiver Regulations
- The Commissioner may waive certain regulations for demonstration projects involving new technologies in pharmacy, provided patient safety is not compromised.
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Description
Quiz on the registration requirements for pharmacies, manufacturers, outsourcing facilities, and wholesalers in New York State. Covers certificate validity and endorsement rules.