Authorization for Pharmacies

Pharmacies in Newfoundland and Labrador can apply to NLPB for approval for lock and leave as well as to provide extended pharmacy services such as centralized prescription processing, satellite pharmacies, telepharmacy service, and opioid agonist maintenance treatment.

 

Lock and Leave Approval

As per the Standards of Pharmacy Operation – Community Pharmacy, the dispensary must be able to be secured against entry by the public or other staff, including pharmacy assistants, when a pharmacist or pharmacy technician is not present in the pharmacy. If a pharmacy is accessible to the public or other staff at any time when a pharmacist or pharmacy technician is not present, such as for cleaning, inventory, or overnight stocking, a lock and leave enclosure must be installed and utilized.

All lock and leave enclosures must be approved by the board prior to use. Pharmacists-in-charge can apply for lock and leave approval by completing and submitting the following application:

If installation of the enclosure alters the floor plan of the dispensary, a separate renovation application is also required, in accordance with the Requirements When Renovating a Pharmacy/Dispensary.
 

Please note: The dispensary hours (pharmacist on duty) must be included in your application, but you may adjust these hours at any time by completing and submitting a revised application form.

 

Lock and Leave Guidelines

  • The physical lock and leave enclosure must secure the dispensary.
  • Any area of the pharmacy where patient information, prescription records, or Schedule I and II drugs are stored must also be secured to prevent access by the public or non-registrant staff.
  • The areas listed above must be secured any time the pharmacist or pharmacy technician is not present, even if they are on the pharmacy premises (i.e. meal breaks or extended patient consultations).
  • Physical enclosure:
    • The lock and leave enclosure must be a wall with adequate doors to permit complete security during periods of closure and to permit full access by the public to the dispensary area when professional services are available or be a sliding or folding wall that will completely surround and secure the dispensary area during the period of closure.
    • The wall must be composed of transparent, semi-transparent, or opaque materials, or any combination thereof, and be at least five feet high.
    • The enclosure must have a lockable entrance that prevents access by the public or non-registrant staff when a pharmacist or pharmacy technician is not in attendance.

 

Prescription Pick-up

As per the Standards of Pharmacy Operation – Community Pharmacy, previously-prepared prescriptions may be made available for pick-up when the lock and leave enclosure is secured, in accordance with the following:

  • Such prescriptions must be stored in a secured area outside the lock and leave enclosure that also provides for any special storage considerations, including breakage and refrigeration.
  • The patient’s confidentiality must be protected at all times by ensuring the outer package displays only the patient’s name and address.
  • Any patient or designated agent who picks up a prescription during these times must still be provided with proper and sufficient counseling by the pharmacist.
  • A documented physical or electronic paper trail of all prescriptions picked up, including patient or designated agent signatures, must be retained in the pharmacy.

 

Centralized Prescription Processing (Central Fill)

Centralized prescription processing (central fill) refers to a service one licensed pharmacy provides to another where a central fill pharmacy acts as an agent of the originating pharmacy to prepare and package prescription orders under the originating pharmacy’s direction. The originating pharmacy is responsible for receiving a prescription from a patient, collecting and documenting the relevant patient information, assessing therapeutic appropriateness, identifying and resolving drug-related problems, and providing patient care. Both pharmacies must be located in Newfoundland and Labrador and be licensed by NLPB.

Prior to entering into an arrangement to offer central fill services, the central fill pharmacy must develop a policy and procedure manual outlining workflow, privacy and confidentiality measures, communication between participating pharmacies, prescription tracking, and quality assurance processes. The policy and procedure manual must be submitted with the following completed application:

Once the pharmacy is authorized, prior to initiating central fill services, the central fill pharmacy must provide the originating pharmacy with a copy of the policy and procedure manual and both pharmacies must enter into a written agreement that outlines the services to be provided and the roles, responsibilities, and accountabilities of each pharmacy.

For more information regarding the requirements and responsibilities of pharmacies entering a central fill agreement, please review the Licensing Requirements for Centralized Prescription Processing (Central Fill) Policy.

 

Satellite Pharmacies

Satellite pharmacies are designed to expand pharmacy services and increase accessibility to a pharmacist in areas where conventional practice is not available. All satellite pharmacies must be associated with a licensed (primary) pharmacy and must not be located within 30km of an existing licensed pharmacy site.

Existing pharmacies intending to operate a satellite pharmacy in addition to their licensed pharmacy must complete and submit the following application with all relevant fees (see Fees & Timelines for a list of fees) and a detailed diagram of the layout of the satellite pharmacy at least 30 days prior to the proposed opening date:

 

Schedule an inspection

Once your application is approved, NLPB staff will contact the pharmacist-in-charge to schedule an inspection of the proposed site prior to the opening of the satellite pharmacy.

 

Close a satellite pharmacy

If you intend on closing a satellite pharmacy, the pharmacist-in-charge is required to contact NLPB as soon as possible for direction on how to proceed.

A satellite pharmacy must cease operation within 60 days of being given notice by NLPB that a pharmacy licence has been issued for a pharmacy within 30km of the satellite pharmacy.

 

For more information regarding the licensing and operating requirements of a satellite pharmacy, please review the Licensing Requirements for Satellite Pharmacies in Rural Communities without Conventional Pharmacy Service Policy.

 

Telepharmacy

Telepharmacy is the provision of pharmacy services to rural and remote hospitals or facilities that are not regularly staffed by a pharmacist and usually takes place via a two-way video telecommunication link between a licensed pharmacy and a remote site. A registered pharmacist at a licensed pharmacy site (primary pharmacy) supervises a pharmacy technician or assistant at a remote site at all times through the use of remote face-to-face technology using audio, video, and computer links as the pharmacy technician or assistant prepares the prescription drug for dispensing by the pharmacist. The Pharmacist-in-Charge of the primary pharmacy is responsible for all activity at the remote site. All remote sites must be associated with a licensed (primary) pharmacy and located in an area of the province that does not have suitable access to necessary hospital pharmacy services.

Prior to applying to operate a remote site via telepharmacy, the pharmacist-in-charge must develop a policy and procedure manual. This manual must be submitted with a detailed diagram of the layout of the remote site and the following completed application with all relevant fees (see Fees & Timelines for a list of fees)  at least 30 days prior to the proposed opening date:

 

Please note: An application must be submitted for each new remote site location.

 

Schedule an inspection

Once your application is approved, NLPB staff will contact the pharmacist-in-charge to schedule an inspection of the remote site prior to the opening of the telepharmacy.

 

For more information regarding the licensing and operating requirements of a telepharmacy, please review the Licensing Requirements for Hospital Pharmacies providing Telepharmacy to Remote Hospital Sites.

 

Opioid Agonist Maintenance Treatment

Opioid Agonist Maintenance Treatment (OAMT) is based on harm reduction and serves to bring normal functioning back to an individual suffering from opioid use disorder. Pharmacy professionals are key to OAMT access. A pharmacy team’s decision to provide OAMT services requires thoughtful consideration of professional ethics as well as the capacity of the pharmacy to undertake the associated activities safely and effectively.

Prior to applying to offer OAMT services, the pharmacist-in-charge must ensure all necessary operational requirements are met pertaining to pharmacy layout and design, hours of operation, staff, security, inventory control, policies and procedures, documentation and retention requirements, and references and resources. If you are considering offering OAMT services at your pharmacy, please review the Standards for the Safe and Effective Provision of Opioid Agonist Maintenance Treatment on the Standards, Guideline, Policies, & Positions page of this website. All pharmacist staff members that will be participating in OAMT services must be authorized to do so by NLPB.

Once all relevant documentation has been reviewed and appropriate processes have been implemented, the pharmacist-in-charge is required to complete and submit the following application prior to offering the service:

 

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