Pill press controlled equipment notification
One of the purposes of the Act is to track Controlled Equipment throughout its lifecycle. This purpose is achieved by keeping records of the Controlled Equipment in the Pill Press Online Registry. In order to establish a comprehensive, consistent, and reliable database, the Registrar requires that all Controlled Equipment be registered and clearly identifiable. All Controlled Equipment must be registered through the Pill Press Online Registry Equipment Notification process.
The BC industry sector has multiple types of equipment for the purpose of producing a variety of products. Controlled Equipment under the Act includes the following:
- Pill presses
- Encapsulators or gel press machines
- Dies, moulds or punches ordinarily used with a Pill Press, or Encapsulator machine
- Pharmaceutical mixer or blender
This includes above equipment that is automated or semi-automated (in the common meaning of the words). 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.
- Automated means having the capacity to operate for an extended period of time with no human attention.
- Semi-Automatic means any combination that consists of the synthesis of automated and human force production to achieve a task.
- Capable of Being Automated means any potential authorized or unauthorized modification/conversion that seeks to either improve operational efficiency or change operating characteristics of equipment for the purpose of replacing, assisting, or enhancing the manual human force production.
Pill Press (includes Tablet Press) means a machine whether semi-automatic, automated or capable of being automated, to be used to compact or mould powdered, granular or semi-solid material to produce cohesive solid tablets, or fill capsules with powdered, granular, semi-solid or liquid material.
Encapsulator (includes Gel Press) means a machine, whether semi-automatic, automated or capable of being automated, that can be used to fill capsules with any powdered, granular, semi-solid or liquid material.
- “Die” means a tool or device to cut, shape, stamp, or form a wide variety of products to a desired finish.
- “Mould” means a hollow cavity, form, or matrix into which a liquid or semi-liquid material is placed to take a desired shape upon cooling or drying into a finished product.
- “Punch” means a tool that comprises of an upper and lower part that works conjointly to change the size or shape of a piece of material by exerting force to the material/workpiece that is typically held in place by a die.
Dies, moulds and punches are exempt from the notification requirement on the part of the authorized owner in the circumstances listed at section 5(2)(a), (b) and (c) of the Act (see section 5(3) of the Act for dies and section 12 of the Regulation for moulds and punches). As a result, a purchaser is exempt from the requirement to report the purchase of dies, moulds, or punches that were sold to them; however, the Registered Seller must still report sales of dies, moulds, or punches.
All Owner Category types under the Act must buy dies, moulds, and punches only from a Registered Seller, when buying in BC.
A pharmaceutical mixer or blender is not Controlled Equipment 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 the Health Professions Act or the Pharmacy Operations and Drug Scheduling Act, or
- By an individual in their personal capacity.
“Compounding” means the combining or mixing together of two or more ingredients to create a final product in an appropriate form for dosing / consumption. Within the meaning of the Act and Regulation, “compound” refers to combining a drug or natural health product that the person is authorized to compound.
“Personal Use” means utilizing Controlled Equipment for a particular purpose other than commercial or industrial manufacturing, preparation or production.
After a business registers a piece of Controlled Equipment through the Equipment Notification process on the Pill Press Online Registry, the system will generate and assign a unique Equipment Registry Number to that piece of equipment. The unique Equipment Registry Number must accompany the piece of Controlled Equipment for the rest of its lifecycle.
To help the Registrar track each piece of Controlled Equipment throughout its lifecycle, it is recommended that the business etch the Equipment Registry Number into the corresponding piece of equipment.
Registered Sellers are required to record the Equipment Registry Number of the Controlled Equipment on the Record of Sale form and provide a copy to the purchaser in order for them to register the purchased Controlled Equipment on the Pill Press Online Registry.
Since the piece of Controlled Equipment sold has a unique Equipment Registry Number, the Controlled Equipment will be transferred from the inventory of the Registered Seller to the purchaser’s inventory after both the seller and the purchaser have notified the Registrar about the sale.
Once the Equipment Notification has been processed, the Registrar will issue a Controlled Equipment certificate and place a pdf on the client Dashboard, which the business can print
It is recommended that the business print each Controlled Equipment certificate once issued and keep it at the location where that piece of Controlled Equipment is ordinarily stored. The business may be requested to provide evidence that the Registrar has approved or confirmed they can own, use, or possess that piece of Controlled Equipment.
Although the Controlled Equipment certificate does not expire, there is an obligation on the business to keep the Registrar updated on any changes to the piece of Controlled Equipment, such as: sale, loss, theft, destruction, or change in location where it is ordinarily stored.
Owners have an ongoing obligation to keep the Registrar updated about the location at which each piece of Controlled Equipment is ordinarily stored. This will help the Registrar track the Controlled Equipment throughout its lifecycle.
“Dwelling House” means:
- All or part of a building or structure that a person keeps or occupies as a permanent or temporary residence and the land under the building or structure, including:
- land that is contiguous to the building or structure and that the person may use in conjunction with the building or structure, and
- a building or structure or land referred to in in subparagraph (i), or
- A unit that is designed to be mobile and to be used on a permanent or temporary basis as a residence, including:
- land that is contiguous to the unit and that the person may use in conjunction with the unit, and
- a building or structure on land referred to in subparagraph (i).
Section 5(1) of the Act requires all owners of Controlled Equipment to ensure that Controlled Equipment is stored securely and in accordance with the Regulations, if any. This is to prevent unauthorized individuals from accessing the Controlled Equipment and the possible production of unsanctioned or illegal products.
The Registrar requires all owners of Controlled Equipment to take the necessary steps to ensure that Controlled Equipment is stored securely, including but not limited to:
- No equipment is left unattended in an open public space or in a space easily or frequently accessible by individuals not permitted to possess or use Controlled Equipment;
- Controlled Equipment possessing computer process controls that have a password feature need their password protection to be enabled to ensure that only authorized employees or agents can direct the operations of equipment;
- All equipment not in use is placed in premises where only those permitted to access the equipment control the ability to enter;
Table top and easily movable equipment are securely fastened to an immovable object with an adequate security device, such as a lock.
Owners are responsible to notify the Registrar of any piece of Controlled Equipment they own, use, or possess by adding them to their list of Controlled Equipment in the Pill Press Online Registry. Owners can see and manage their inventory of Controlled Equipment on their Client Dashboard in the Pill Press Online Registry.
When Owners acquire a piece of Controlled Equipment, they must report the transaction to the Registrar through the Pill Press Online Registry within 10 days, in the form of an Equipment Notification (See Reporting Sales).