Pill Press Frequently Asked Questions

About the Act

Owner Categories

Authorized Owner

Registered Sellers

Waivers

Controlled Equipment

Equipment Notification

Sales/Selling

Changes

Transitional

Compliance & Enforcement


About the Act

What is the Pill Press and Related Equipment Control Act?

The Pill Press and Related Equipment Control Act restricts the ownership, use, possession, and sale of equipment that has the potential to be used to make illicit drugs. It creates a registry for each piece of Controlled Equipment and tracks it throughout the equipment’s life cycle, including its ownership and location.

Top of Page ↑

Why did the government decide to regulate Controlled Equipment?

Pill Presses are used by drug traffickers to transform powdered drugs such as fentanyl into counterfeit pills, at enormous profits for organized crime. Pills created by drug traffickers do not have a standard dose, carrying high risk of overdose by users. Better control over who has access to Pill Presses was requested by law enforcement partners and is part of the provincial government’s public safety strategy to address the opioid crisis.

How easy is it for my business to register Controlled Equipment?

There are legitimate and illegitimate users of Pill Presses and related equipment. The purpose of the Pill Press Online Registry is to track Controlled Equipment without undue administrative burden on legitimate owners of Pill Presses and related equipment. The Pill Press Registry has a user-friendly client interface, online application submission features, and a client dashboard that allows legitimate owners to easily register and track their equipment. The Pill Press Registry is important to building an information database regarding Controlled Equipment to assist in ongoing regulatory efforts.

Since the Pill Press Registry will contain an inventory of legitimate equipment and owners, law enforcement will have the tools to interdict the illegal production of counterfeit pills. Police will have the ability to seize Controlled Equipment in the hands of anyone who is not authorized to possess it under the Act.

Top of Page ↑

How can I sign on to the Pill Press Registry?

The Pill Press Registry can be accessed from the government website. The business will be brought to a BCeID login page. BCeID is the method used to authenticate businesses that are registering their Controlled Equipment. This ensures that all businesses interacting with the Pill Press Online Registry have been independently verified and authenticated by the government.

Only clients with a Business BCeID can access the Pill Press Online Registry. If a business does not already possess a Business BCeID, they can obtain one by contacting BCeID. All businesses that intend to interact with the Pill Press Online Registry should ensure that they have an up-to-date Business BCeID.

Owner Categories

Who can own, use, or possess Controlled Equipment? 

In order for a business to own, use, or possess Controlled Equipment, they must be part of an authorized owner category. In general, anyone who does not possess an owner category is not permitted to own, use, or possess Controlled Equipment.

There are three owner categories on the Pill Press Online Registry: Authorized Owners, Registered Sellers, and Waiver holders. If a business holds one or more owner category, they are considered authorized under the Act to own, use, or possess Controlled Equipment, subject to the terms & conditions on their certificates.

Top of Page ↑

Authorized Owner

What does the Authorized Owner category mean? 

The Authorized Owner category is a term used in the Pill Press Online Registry to describe a business that is already permitted to own, use, or possess Controlled Equipment under the Act by virtue of their licensing under another regulatory regime. Currently, this owner category only includes businesses authorized under an enactment in BC or Canada to manufacture a drug or natural health product, such as holders of valid drug establishment or site licences issued by Health Canada.

Before a business may register its inventory of Controlled Equipment in the Pill Press Online Registry, the Registrar will conduct a simple confirmation process to verify the validity of the drug establishment or site licence issued to the business.

How do I confirm my Authorized Owner category?

To confirm an Authorized Owner category, the business should firstly ensure that they meet the criteria set out on the Pill Press website. To access the Pill Press Online Registry, the business clicks the “log in” button on the Pill Press website.

After authenticating through Business BCeID, a first-time visitor will be invited to fill out their business profile information, such as addresses and contact information. The business profile page should be periodically updated as business information changes.

The business will then be directed to their Dashboard. From the Dashboard, the business may select the “Authorized Owner” option, which will launch the confirmation process. The status of the confirmation process will be tracked on the client’s Dashboard.

Once the Registrar has confirmed the business as an Authorized Owner, the business will receive an email notice and be invited to return to their Dashboard to provide Equipment Notification for their inventory.

Top of Page ↑

What if I use my Controlled Equipment to make things other than drugs or natural health products?

Even if a business is confirmed in the Authorized Owner category (i.e. holding a valid drug establishment or site licence issued by Health Canada), this does not authorize the business to manufacture other products using their Controlled Equipment.

If a business is using Controlled Equipment to manufacture products other than drugs or natural health products (as per their Health Canada licence), the business must obtain a Waiver to manufacture these other products.

What if I am planning to apply for a drug establishment licence or a site licence from Health Canada, but I don’t have one yet?

A business must possess at least one owner category authorizing them to own, use, or possess Controlled Equipment under the Act. If a business is waiting for a Health Canada licence to manufacture drug or natural health products, they must obtain a Waiver to own, use, or possess their Controlled Equipment. Once Health Canada issues a drug establishment or site licence, the business may apply for confirmation under the Authorized Owner category.

Top of Page ↑

Registered Sellers

What does the Registered Seller owner category mean? 

The Registered Seller owner category is a term used to describe a business that has applied to the Registrar and received a registration certificate under the Act to sell Controlled Equipment. All businesses located in BC are required to obtain a seller registration before selling any Controlled Equipment.

Those BC businesses who wish to sell Controlled Equipment, either inside or outside of BC, must apply for the Registered Seller registration by April 1, 2019.

How do I apply to be a Registered Seller?

To apply for a Registered Seller owner category, the business should firstly ensure that they meet the criteria set out on the Pill Press website. To access the Pill Press Online Registry, the business clicks the “log in” button on the Pill Press website.

After authenticating through Business BCeID, a first-time visitor will be invited to fill out business profile information, such as addresses and contact information. The business profile page should be periodically updated as business information changes.

The business will then be directed to their Dashboard. From the Dashboard, the business may select the “Registered Seller” option, which will launch the application process. Part of the application process will include the applicant listing all their owners and managers so that criminal record checks can be conducted on them.

The status of the Registered Seller application will be tracked on the client’s Dashboard. When approval is granted by the Registrar for the Registered Seller owner category, the business will receive an email notice and have the option to print their seller registration certificate from their Dashboard. The seller registration certificate will show a unique system-generated registration number for the business.

Upon the business coming into possession of Controlled Equipment, they will be required to return to their Dashboard to provide Equipment Notification for their inventory, within 10 days.

Top of Page ↑

I am applying to be a Registered Seller. How do I go through the criminal record check process?

Only Registered Seller applicants must obtain a criminal record check for their owners and managers. This is because special obligations are placed on sellers of Controlled Equipment to ensure that they sell only to authorized businesses, and to maintain adequate records of equipment sales.

Within the Registered Seller application, the applicant will be asked to provide the names and contact information for all their owners and managers. Once the application is submitted, the Pill Press Online Registry will send an email to each owner and manager listed and requests that they complete a consent for criminal record check. The consent will allow the Registrar to conduct a criminal record check, a police information check, and correctional service information check (Prescribed Checks).

The Registrar will evaluate the Registered Seller application for suitability, taking into consideration the results of Prescribed Checks for all owners and managers listed in the application.

What is meant by the term “owner” or “manager”?

As described above, the owners and managers of the Registered Seller applicant will be asked to consent to Prescribed Checks as part of the application process. Who will be considered an owner or manager depends on the legal structure of the business.

Owners include the following:

  • If a public company or private company, then all directors and officers
  • If a registered society, then all directors and senior managers.
  • If a partnership, then all partners. If a limited liability partnership, then the general partner.
  • If a sole proprietorship, then the sole proprietor.

Managers include any positions responsible for overseeing the day-to-day operation of the business. In large businesses, the manager is the position that oversees the manufacturing operations that include Controlled Equipment.

Top of Page ↑

Can a Registered Seller make a product with Controlled Equipment?

The Registrar will apply a standard limit and condition on all seller registration certificates permitting demonstrations of Controlled Equipment for operation purposes.

If a business otherwise wants to manufacture a product with Controlled Equipment, they must obtain a Waiver from the Registrar.

Waivers

What does the Waiver Holder owner category mean? 

The Waiver owner category is available to a business that wishes to own, use, or possess Controlled Equipment but does not fall under the criteria for the Authorized Owner or Registered Seller owner categories. A Waiver holder is a term used to describe a business that has applied to the Registrar and received a waiver certificate under the Act.

A business that does not meet the criteria for other owner categories that wishes to own, use, or possess Controlled Equipment must apply for a Waiver by April 1, 2019.

Top of Page ↑

How do I apply for a Waiver?

To apply for a Waiver owner category, the business should firstly ensure that they meet the criteria set out on the Pill Press website. To access the Pill Press Online Registry, the business clicks the “log in” button on the Pill Press website.

After authenticating through Business BCeID, a first-time visitor will be invited to fill out business profile information, such as addresses and contact information. The business profile page should be periodically updated as business information changes.

The business will then be directed to their Dashboard. From the Dashboard, the business may select the “Waiver” option, which will launch the application process. The status of the Waiver application will be tracked on the client’s Dashboard.

When approval is granted for the Waiver owner category, the business will receive an email notice and have the option to print their waiver certificate from their Dashboard. The waiver certificate will show a unique system-generated waiver number for the business.

Upon the business coming into possession of Controlled Equipment, they will be required to return to their Dashboard to provide Equipment Notification for their inventory, within 10 days.

Can registrants under the Health Professions Act (such as pharmacists, naturopaths, or practitioners of traditional Chinese medicine) own, use, or possess Controlled Equipment?

At this time, the provisions in the Act relating to authorized health professionals are not being brought into force. As a result, authorized health professionals are not, at this time, considered authorized owners under the Act. The government has consulted with the relevant colleges of health professionals, and it appeared only a small minority may need the type of Controlled Equipment contemplated by the Act (i.e. semi-automated or capable of being automated). Equipment that is worrisome to the police is more focused on larger scale production of pills, rather than compounding for individual prescriptions done by health professionals.

Individual health professionals can apply for a Waiver to own, use, or possess Controlled Equipment if they need it for a legitimate purpose. Although the Registrar may, in the future, add health professions under the Authorized Owner category to reflect the corresponding provisions of the Act being brought into force, as applicable, currently registrants under the Health Professions Act are not permitted to own, use, or possess Controlled Equipment unless they have been issued a Waiver by the Registrar.

Top of Page ↑

Controlled Equipment

What is included as “Controlled Equipment” under the Act? 

Under the Act, certain types of equipment are considered “Controlled Equipment” and it is not lawful to own, use, or possess this equipment unless part of an Authorized Owner category.

"Controlled Equipment" includes:

  • Pill Press (includes Tablet Press): A machine, whether semi-automatic, automated or capable of being automated, that may be used to compact or mould powdered, granular or semi-solid material to produce cohesive solid tablets.
  • Encapsulator (includes Gel Press): A machine, whether semi-automatic, automated or capable of being automated, that can be used to fill capsules with powdered, granular, semi-solid or liquid material.
  • Dies, moulds or punches ordinarily used with a Pill Press, or Encapsulator machine.
  • Pharmaceutical mixer or blender, except if the pharmaceutical mixer or blender is used to make tablets or capsules in the course of compounding a drug by a person authorized to do so under Health Professions Act or the Pharmacy Operations and Drug Scheduling Act, or by an individual for personal use.

What does “capable of being automated” mean in terms of Controlled Equipment?

In general, manual equipment is not considered Controlled Equipment. However, if the manual equipment can be automated, for example by attaching a motor to operate the hand crank, then it becomes Controlled Equipment under the Act and it must be registered.

As well as “capable of being automated” equipment, all Controlled Equipment that is automated or semi-automated (in the common meaning of the words) must be registered through the Pill Press Online Registry’s Equipment Notification process.

Top of Page ↑

Equipment Notification

How do I register my Controlled Equipment under the Act? 

To provide Equipment Notification to the Registrar, the business should ensure that their equipment meets the criteria for Controlled Equipment set out on the Pill Press website.

To access the Pill Press Online Registry, the business clicks the “log in” button on the Pill Press website. The business should already be familiar with this process after completing their owner category application.

After authenticating through Business BCeID, the business will be directed to their Dashboard. From the Dashboard, the business may select the “Equipment Notification” option, which will launch the notification process.

The status of the Equipment Notification process will be tracked on the client’s Dashboard, and within the Equipment Notification application, as each piece of Controlled Equipment is separately submitted for review before adding to the business’s equipment inventory.

A business has an ongoing obligation to keep their Controlled Equipment inventory up-to-date, and to submit an Equipment Notification within 10 days of coming into possession of a new piece of equipment. Also, the business must record changes in the status of existing equipment on their inventory through accessing applicable change processes from their Dashboard.

Why do I have to enter each piece of Controlled Equipment separately?

The main purpose of the Pill Press Registry is to track each piece of Controlled Equipment throughout its life cycle. The Registrar will assign compliance and enforcement inspections based on the physical location of each piece of equipment. While some businesses may store all Controlled Equipment at the same location, others may have several manufacturing sites throughout BC.

The Pill Press Online Registry also tracks changes to equipment status, like if it is sold, lost, stolen, or destroyed. Registering each piece of equipment separately reduces confusion about the status of individual pieces of equipment and facilitates accurate tracking by the Registrar. However, all Controlled Equipment can be registered using the same Equipment Notification process.

When an Equipment Notification is completed, the business will receive an email notice and have the option to print the equipment certificate from their Dashboard. Each piece of equipment will be assigned a unique system-generated equipment registry number.

Top of Page ↑

What about notice requirements for dies, moulds, and punches?

  • Even though dies, moulds and punches used with Pill Press machinery are considered Controlled Equipment, owners are not required to provide an Equipment Notification to the Registrar regarding these pieces of equipment. It would be impractical for owners to track and notify the Registrar about each one of these pieces of small equipment.
  • However, since dies, moulds, and punches are Controlled Equipment, the police and Inspectors have the authority under the Act to seize them from anyone who cannot produce proof of their authority to have them.
  • All owner categories to should exercise caution when purchasing dies, moulds, and punches for their Pill Presses machinery to ensure that they are only purchasing this equipment in BC from a Registered Seller.

What if my Controlled Equipment does not have a make, model or serial number, for example if it was custom built (out of spare parts)?

  • The Pill Press Online Registry requires a unique identifier for each piece of Controlled Equipment so that the Registrar can accurately track equipment throughout its lifecycle. However, some equipment is custom built, sometimes out of spare parts, and may not have a manufacturer’s serial number.
  • The Equipment Notification process includes a means of registering pieces of Controlled Equipment without a manufacturer’s make, model, or serial number. If there is no manufacturer’s serial number for a piece of equipment, the client will be requested to provide a “key part” serial number and upload photos for identification purposes. Once registered, this equipment will be assigned a unique system-generated equipment registry number for ongoing tracking.

Top of Page ↑

I want to register my Controlled Equipment. Why can’t I see an Equipment Notification option on my Dashboard?

The Pill Press Online Registry is set up in two stages: owner category, and equipment notification. This is so that any business registering Controlled Equipment can be confident that they are permitted to own, use, or possess it.

There are three owner categories on the Pill Press Online Registry: Authorized Owners, Registered Sellers, and Waiver holders. Once the Registrar has confirmed/approved an owner category, the Equipment Notification option on the client Dashboard will be enabled so that the business can register their Controlled Equipment, within 10 days.

Sales/Selling

What does the term “sell” mean under the Act?

The term “sell” under the Act includes: offer for sale, expose for sale, have in possession for sale, distribute, give, transfer, lend, send, rent, or otherwise dispose of, whether for consideration (i.e. money) and whether by wholesale, retail, or private sale.

Before anyone can “sell” Controlled Equipment in BC, they must have obtained their Registered Seller registration. If a business acts as a broker or supplier of alternative ownership arrangements (i.e. renting, leasing, lending) for Controlled Equipment, these are considered controlled activities. Businesses are encouraged to consult with the Registrar before proceeding with these types of controlled activities, by contacting PillPressLicensing@gov.bc.ca.

Top of Page ↑

What are the obligations of Registered Sellers when they sell Controlled Equipment?

Before a BC business can “sell” Controlled Equipment, they must hold a Registered Seller registration. A Registered Seller must also ascertain that they do not sell Controlled Equipment to any person in British Columbia other than to an authorized owner under the Act. As such, a Registered Seller must collect from an intended purchaser sufficient information to confirm their identity, and to ensure that the purchaser is permitted to own, use, or possess Controlled Equipment. A Registered Seller is also required to report details of the sale to the Registrar, in the manner and form required by the Registrar.

During a sales transaction for Controlled Equipment, the Registered Seller must collect:

  • Purchaser information, such as: the legal name of the purchaser, photo ID number to confirm identity; purchaser contact information, purchaser’s authorization information (i.e. drug establishment or site licence, waiver number, registration number); and, if known, the civic address where the purchaser will ordinarily store the equipment and whether storage will be in a dwelling house.
  • Details of the sale, such as: the date on which the sale was made; description of the equipment sold (including make, model, serial number and/or equipment registry number); the seller’s registration number; and, method of payment used.

There is a prescribed Record of Sale form which must be filled out by the Registered Seller each time they “sell” a piece of Controlled Equipment. The Record of Sale form can be found on the Pill Press website.

The Registered Seller must provide a copy of the completed Record of Sale form to the purchaser, as this will provide essential information for BC purchasers to complete their Equipment Notification within 10 days. Purchasers from outside of BC are not required to provide Equipment Notification; however, Registered Sellers are obligated to report all sales, whether the purchaser was from inside or outside of BC.

 As a Registered Seller, how do I report a sale of Controlled Equipment?

Before selling a piece of Controlled Equipment, the Registered Seller must have provided Equipment Notification to add the equipment to the seller’s inventory. The Registered Seller can see their inventory of Controlled Equipment on their client Dashboard in the Pill Press Online Registry.

When the Registered Seller sells a piece of Controlled Equipment in their inventory, they have 10 days to report the sale on the Pill Press Online Registry. The Dashboard will have a link that allows the seller to enter key information about the sale. If the purchaser is in BC, the Registrar will await Equipment Notification from the purchaser before transferring the piece of Controlled Equipment from the seller’s inventory to the purchaser’s inventory on their client Dashboard.

At this time, the Registered Seller is not required to upload a copy of the completed Record of Sale form to report a sale’s transaction to the Registrar; however, the seller is obligated to keep all records related to each sale for a period of two years after acknowledgment of the sale by the Registrar, and these records may be reviewed by Inspectors.

Top of Page ↑

Changes

How do I notify the Registrar of changes that affect my Controlled Equipment?

All owner categories have an ongoing obligation to notify the Registrar of certain changes that affect Controlled Equipment, such as:

  • If the owner acquires or sells a new piece of Controlled Equipment;
  • Changes to the location where the equipment is ordinarily stored; and,
  • If a piece of Controlled Equipment is lost, stolen, or destroyed.

In the case of acquiring a new piece of Controlled Equipment, the business is required to advise the Registrar within 10 days, by filling out an Equipment Notification application for that piece of equipment, which can be accessed off the client Dashboard in the Pill Press Online Registry.

In the case of the sale of a piece of Controlled Equipment, please see the section on sales – only Registered Sellers can sell equipment and they must follow strict rules when recording and reporting sales.

In the case of changes to the location of a piece of Controlled Equipment in the business’s inventory, please access the location change process from the client Dashboard to report a change in location where the equipment is ordinarily stored.

In the case of reporting that a piece of Controlled Equipment has been lost, stolen, or destroyed, please access the lost/stolen/destroyed process from the client Dashboard.

How do I notify the Registrar of changes to my business or owner category status?

Authorized Owners whose Health Canada licensing status has changed after July 1, 2019, must report these circumstances to the Registrar. If the business’s drug establishment or site licence has been suspended, replaced, or cancelled, the business must report this to the Registrar within 10 days, by sending an email to PillPressLicensing@gov.bc.ca, and awaiting further instructions.

Registered Sellers must report if any of their owners or managers have been charged with or convicted of an offence under the Act, the Criminal Code, the Controlled Drugs and Substances Act (Canada), or the Cannabis Act (Canada), within 10 days, by sending an email to PillPressLicensing@gov.bc.ca, and awaiting further instructions.

Top of Page ↑

Transitional

What are the obligations for people who own, use, or possess Controlled Equipment starting in January 15, 2019? 

Those businesses who own, use, or possess Controlled Equipment have a number of obligations once the legislation comes into force on January 15, 2019.

Since Health Canada licensed fabricators are already considered Authorized Owners, they must have their Authorized Owner status under the Act confirmed and provide an Equipment Notification by July 1, 2019.

Other businesses who wish to own, use, or possess Controlled Equipment must apply for a Waiver or Registered Seller certificate by April 1, 2019.

Compliance and Enforcement

Will my Controlled Equipment be inspected?

The Act allows for the appointment of Inspectors to undertake compliance and enforcement activities. These Inspectors have special provincial constable appointments and can issue violation tickets.

The Registrar will establish an inspection schedule for businesses that have been granted an owner category under the Act. Among other things, Inspectors will confirm that the business:

  • Holds the correct owner category for the controlled activities undertaken.
  • Is acting in accordance with the limits and conditions outlined on their owner certificate.
  • Notified of changes in business or owner category status, including changes to Health Canada licensing status and criminal record changes for Registered Seller owners and managers.
  • Has provided Equipment Notification for all their Controlled Equipment.
  • Has accurately reported the location where each piece of Controlled Equipment is ordinarily stored.
  • Is securely storing all Controlled Equipment.
  • Has reported changes to Controlled Equipment in their inventory, such as if the equipment was lost, stolen, or destroyed.
  • If a Registered Seller, has maintained sales records and accurately reported sales of inventory.
  • Maintained required records for the period of time established in the Act and regulations.

Top of Page ↑

What happens if I do not comply with the requirements of the Act or regulations?

An Inspector may exercise powers under the Act to issue a “stop order” that prevents a business from using Controlled Equipment, or the inspector may seize Controlled Equipment if evidence is not produced that shows the business is authorized to own, use, or possess the equipment. The Police also have authority to seize Controlled Equipment under certain circumstances.

There are several offences detailed under section 22 of the Act. Offence Act penalties are outlined in Appendix 2 of the Regulation. If a business does not comply with the Act, they may be subject to fines under the Violation Ticket Administration and Fines Regulation of either $288 or $575, depending on the nature of the infraction. Details of potential fines can be found on the Pill Press website

Serious or repeated infractions may result in prosecution under section 26 of the Act, which carries penalties of up to $500 000 or liability to a term of imprisonment not exceeding 6 months, or both.

Top of Page ↑