New York State Pharmacy Registration

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Questions and Answers

What is the minimum temperature range required for storage of drugs in a refrigerator?

5 to 15 degrees Centigrade

0 to 10 degrees Centigrade

4 to 12 degrees Centigrade

2 to 8 degrees Centigrade (correct)

What is the minimum height of the partition required for a pharmacy operated as a department of a general merchandising establishment?

9 feet 6 inches (correct)

8 feet

12 feet

10 feet

What is the purpose of the exhaust hood and filter system in a pharmacy that dispenses radioactive drugs?

To provide ventilation for the pharmacy staff

To maintain a consistent temperature in the pharmacy

To remove radioactive particles from the air (correct)

To provide additional lighting in the pharmacy

What is the minimum number of contact hours of didactic instruction required for a pharmacist to dispense radioactive drugs?

200 contact hours Signup and view all the answers

What is the primary purpose of the laminar flow hood in a pharmacy that dispenses radioactive drugs?

To provide a sterile environment for handling radioactive materials Signup and view all the answers

What is the minimum number of hours of clinical nuclear pharmacy training required for a pharmacist to dispense radioactive drugs?

500 hours Signup and view all the answers

What is the purpose of the single-channel and/or multichannel scintillation detection system in a pharmacy that dispenses radioactive drugs?

To detect the presence of radioactive materials Signup and view all the answers

What is the certification required for a pharmacist to dispense radioactive drugs?

Certification as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties Signup and view all the answers

What is the purpose of the chromatography apparatus in a pharmacy that dispenses radioactive drugs?

To separate and purify radioactive compounds Signup and view all the answers

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?

The pharmacy is not required to meet the requirements of the paragraph for the continuance of registration to the same registrant Signup and view all the answers

Under what circumstances can a pharmacist or pharmacy intern fill a prescription without violating the requirements of this subparagraph?

If the patient refuses to supply information necessary for maintenance of a medication profile or to accept counseling. Signup and view all the answers

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?

An unlicensed assistant. Signup and view all the answers

Who is responsible for conducting counseling sessions?

A pharmacist or pharmacy intern. Signup and view all the answers

What must a pharmacist or pharmacy intern include with each prescription?

A written offer to counsel the patient or person authorized to act on behalf of the patient. Signup and view all the answers

What must be provided with the written offer to counsel for pharmacies engaged primarily in mail order delivery of prescriptions?

A toll-free telephone number for long distance calls. Signup and view all the answers

When must a pharmacist or pharmacy intern personally counsel a patient or person authorized to act on behalf of the patient?

Only when the patient requests counseling. Signup and view all the answers

What can be included in counseling sessions?

Topics such as potential adverse effects, interactions, and therapeutic complications. Signup and view all the answers

Under what circumstances can a pharmacist or pharmacy intern refuse to dispense a prescription?

If, in their professional judgment, potential adverse effects or interactions could endanger the health of the patient. Signup and view all the answers

How can counseling be conducted?

Via telephone or in-person face-to-face meetings. Signup and view all the answers

Who can request counseling?

The patient or a person authorized to act on behalf of the patient. Signup and view all the answers

What is required for a certificate of registration to be endorsed to another address?

It requires a finding by the board that the new location meets certain requirements. Signup and view all the answers

Within what time frame must the State Board of Pharmacy be notified of a change in officers for a corporation?

30 days Signup and view all the answers

What is the minimum notice period for an application for endorsement to a new address?

30 days prior to the expected date of relocation Signup and view all the answers

What must registered establishments ensure regarding their premises?

They must be equipped with proper sanitary appliances and kept clean. Signup and view all the answers

In the event of a disaster like fire or flood, how soon must the State Board of Pharmacy be notified?

48 hours Signup and view all the answers

What is required to obtain or continue a certificate of registration for a pharmacy?

Compliance with cleanliness and sanitary standards. Signup and view all the answers

Where must a sign displaying the full name of the registrant be prominently displayed?

On the exterior of the premises or directory of a multi-tenanted structure. Signup and view all the answers

What does Section 63.8 of the outlined provisions specifically focus on?

Requirements for the registration of nonresident establishments. Signup and view all the answers

A pharmacy dispensing both radioactive and non-radioactive drugs must:

Store both types of drugs in a designated, secure area. Signup and view all the answers

The patient medication profile should include all of the following EXCEPT:

The patient's social security number. Signup and view all the answers

A prospective drug review before dispensing a prescription includes screening for:

Drug interactions, dosage accuracy, and therapeutic duplication. Signup and view all the answers

When is counseling required for a patient receiving a new prescription?

Only for prescriptions for new medications or changes in dosage, strength, or administration. Signup and view all the answers

Which of the following is NOT a component of required patient counseling?

Details of the patient's insurance coverage and co-pay. Signup and view all the answers

What is the duration for which patient medication profiles must be maintained?

Five years from the date of the last entry. Signup and view all the answers

Who can provide patient counseling according to the content?

A licensed pharmacist or a pharmacy intern. Signup and view all the answers

What is the main purpose of a prospective drug review?

To identify potential drug therapy problems before dispensing the medication. Signup and view all the answers

How can patient counseling be delivered for prescriptions dispensed off-premises?

Through a phone call or written instructions. Signup and view all the answers

According to the content, what should be avoided in the counseling process?

Delegating counseling tasks to individuals not authorized to practice pharmacy. Signup and view all the answers

What is required from a pharmacist at a registered pharmacy when transferring prescription information?

Original prescription information must be transferred directly from one pharmacist to another. Signup and view all the answers

How long must a pharmacy maintain the hard copy of a transferred prescription?

Five years from the date of filling. Signup and view all the answers

What must be included on the hard copy of the transferred prescription by the accepting pharmacist?

The term 'refill transfer' on the face of the hard copy. Signup and view all the answers

Which of the following is necessary for a refill transfer to be valid?

The patient must authorize the refill transfer expressly. Signup and view all the answers

In order to secure registration, a pharmacy must possess which of the following utensils?

Devices capable of measuring volumes from 0.1 ml to 500 ml. Signup and view all the answers

What information must be recorded by the pharmacist who transfers original prescription information?

The date of the transfer and the pharmacist's contact details. Signup and view all the answers

Which of the following statements about automated data processing systems in pharmacies is true?

They must meet specific requirements if accessing a common electronic file. Signup and view all the answers

What constitutes a valid transfer of original prescription information from one pharmacy to another?

Direct communication between two pharmacists. Signup and view all the answers

Which parameter must a pharmacy maintain in its registered area?

A registered pharmacy must have a total area of at least 300 square feet. Signup and view all the answers

What is the maximum number of refills that can be transferred per request?

Only one authorized refill per transfer. Signup and view all the answers

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?

All of the above. Signup and view all the answers

What must the pharmacist or pharmacy intern include with each prescription when dispensing a prescriber approved alternative drug?

A notification explaining that a prescriber approved alternative drug has been dispensed, directions for use, and availability of counseling. Signup and view all the answers

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?

After the drug has been mailed or delivered to the patient. Signup and view all the answers

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?

Two attempts. Signup and view all the answers

If the patient or person authorized to act on behalf of the patient refuses to accept counseling, what action must the pharmacy take?

Document the refusal in the pharmacy's records. Signup and view all the answers

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?

The pharmacist or pharmacy intern. Signup and view all the answers

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?

Any topics that the pharmacist or pharmacy intern deems appropriate in their professional judgment. Signup and view all the answers

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?

In all cases, regardless of whether the patient or person authorized to act on behalf of the patient is successfully contacted. Signup and view all the answers

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?

The pharmacist or pharmacy intern may be subject to disciplinary action. Signup and view all the answers

When dispensing a prescriber approved alternative drug, what is the purpose of the special written notification included with the prescription?

To clearly inform the patient that a prescriber approved alternative drug has been dispensed, provide directions for use, and advise the patient of the availability of counseling. Signup and view all the answers

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?

Every six months Signup and view all the answers

Which of the following is NOT included in the report that outsourcing facilities must submit every six months?

Number of prescription refills Signup and view all the answers

What must a pharmacist or pharmacy intern do when potential drug therapy problems are identified?

Contact the patient or authorized person for counseling. Signup and view all the answers

What must outsourcing facilities maintain records of for a minimum of five years?

Quality control records for beyond use dating and stability Signup and view all the answers

What must be done if the patient refuses the offer for counseling?

The refusal must be documented in the pharmacy records. Signup and view all the answers

In which scenario can a pharmacist refuse to dispense a prescription?

If potential adverse effects or interactions could endanger the patient's health. Signup and view all the answers

What is the primary prerequisite for distribution or dispensing of drugs by an outsourcing facility?

It must also be a New York State registered pharmacy. Signup and view all the answers

What information must registered pharmacies provide regarding their drug retail price list?

A notice must be posted in the pharmacy and on the website. Signup and view all the answers

Which regulatory document must outsourcing facilities comply with according to the requirements mentioned in the content?

Federal Food, Drug, and Cosmetic Act Signup and view all the answers

What is the fee for each certificate issued to a registered manufacturer or wholesaler?

$5 Signup and view all the answers

What is the minimum height requirement for the text on the sign notifying customers of the drug retail price list availability?

One inch. Signup and view all the answers

How should pharmacies inform consumers who receive prescriptions through mail order about the drug retail price list?

Send a printed notice with each delivery. Signup and view all the answers

What role must be present at all times in an outsourcing facility according to the regulations?

A pharmacist licensed and registered to practice in New York State Signup and view all the answers

What is the minimum size requirement for the registered area of an establishment?

300 square feet Signup and view all the answers

In which circumstances can the Commissioner waive regulations related to outsourcing facilities?

To allow demonstration projects using emerging technologies and practices Signup and view all the answers

Who is authorized to personally offer counseling to the patient according to the regulations?

A licensed pharmacist or pharmacy intern. Signup and view all the answers

What must an outsourcing facility submit during initial registration and at each renewal?

Documentation of being registered under the Federal Food, Drug, and Cosmetic Act Signup and view all the answers

Which of the following is NOT a requirement from the pharmacist or pharmacy intern when identifying drug therapy problems?

Document the interaction with the patient. Signup and view all the answers

Who can supervise a wholesaler that does not engage in repacking?

A person with at least two years of education beyond high school Signup and view all the answers

Which is NOT a requirement for a supervisor of an establishment that handles compressed medical gases?

A physician with a medical degree Signup and view all the answers

What is the purpose of the quality control records that outsourcing facilities must maintain?

To determine beyond use dating and stability Signup and view all the answers

What may a pharmacist choose to counsel regarding when identifying drug therapy problems?

Any topics deemed appropriate based on their professional judgment. Signup and view all the answers

Which of the following scenarios would NOT constitute a potential drug therapy problem?

A patient requesting over-the-counter medication. Signup and view all the answers

What is the duration for which records of receipt and disposition of all drugs must be maintained?

Five years Signup and view all the answers

What type of degree is required for an individual supervising the manufacturing and repacking of compressed medical gases?

A bachelor's degree in chemistry, microbiology, or a related field Signup and view all the answers

Which supervisor is not permitted to also supervise another establishment registered by the board?

The supervisor of a wholesaler Signup and view all the answers

What condition must be satisfied for manufacturers or wholesalers to sell drugs?

They may sell drugs only to authorized purchasers as defined by law Signup and view all the answers

What is required for a wholesaler that transfills medical oxygen regarding supervisory personnel?

A person with two years of education beyond high school related to medical gases Signup and view all the answers

Which of the following supervisory qualifications for an outsourcing facility is incorrect?

A person with a master's degree in biochemistry Signup and view all the answers

Which requirement related to the registered establishment's operations is NOT specified?

The establishment must operate 24/7 Signup and view all the answers

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?

When the generic drug is unavailable and the pharmacist agrees to dispense the brand-name product for a price not exceeding the generic substitute's price. Signup and view all the answers

What is the minimum duration for which a pharmacy must retain an electronic prescription or a hard copy of an electronic prescription?

Five years from the date of the most recent filling. Signup and view all the answers

Which of the following is NOT a requirement for an electronic prescription to be considered valid?

The prescription must be written on official prescription paper. Signup and view all the answers

In what instance is a pharmacist specifically required to document the date, hour, and nature of a medical emergency in the prescription record?

When the patient requires a brand-name drug due to a medical emergency and the generic drug is unavailable. Signup and view all the answers

Which of the following is NOT a permissible method for a prescriber to transmit a prescription to a pharmacist?

Verbal communication over the phone. Signup and view all the answers

If a pharmacy maintains an electronic prescription, how should it make the prescription available to the Department upon request?

Provide a printout of the electronic prescription. Signup and view all the answers

What does the term 'electronic signature' refer to in the context of an electronic prescription?

An electronic sound, symbol, or process attached to the prescription, adopted by the prescriber with intent to sign, and secured from unauthorized alteration. Signup and view all the answers

Which of the following is NOT a permissible action for a pharmacist to take when accepting an electronic prescription?

Dispensing the medication to a different patient than the one named in the prescription. Signup and view all the answers

Which of the following best describes the primary objective of encrypting an electronic prescription?

To prevent unauthorized access, alteration, or use of the prescription. Signup and view all the answers

What is the main difference between a prescription transmitted by facsimile and an original hard copy prescription?

Facsimile prescriptions must be manually signed by the prescriber, while original hard copy prescriptions can be electronically signed. Signup and view all the answers

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.