Does Pennsylvania Require a Marijuana Manufacturing License to Make Cannabis Products?
Persons interested in manufacturing cannabis products in Pennsylvania must obtain a medical marijuana grower/processor permit. Title 28 Chapter 1151.21 of the Pennsylvania Code prohibits anyone from processing medical marijuana or medical marijuana products without getting a permit. The license-issuing agency authorized by the Medical Marijuana Act is the Pennsylvania Department of Health, otherwise referred to as the Department of Health of the Commonwealth. Section 304 (b) (2) of the Pennsylvania Marijuana Act also prohibits anyone from incorporating medical marijuana into edible form without a permit. This section describes such an act as unlawful. However, the law would not incriminate a registered patient or caregiver who incorporates medical marijuana into edible form in a bid to aid the digestion of a patient.
The only license applicable for the manufacturing of medical marijuana in Pennsylvania is the grower/processor permit. The grower/processor permit is issued to persons or entities licensed to cultivate medical marijuana or manufacture marijuana products, or both.
Does Pennsylvania Require Licensed Cannabis Manufacturers to Have Cultivation Licenses?
In Pennsylvania, medical marijuana manufacturers are required to obtain a medical marijuana grower/processor permit. This allows the permit holder to cultivate and manufacture marijuana for medical purposes. It also allows them to sell medical marijuana products to other medical marijuana organizations in the state, such as licensed medical marijuana cultivators and manufacturers. Title 28, Chapter 1151.29 of the Pennsylvania Code specifies some conditions that a grower/processor permit holder must meet to be able to sell products to other medical marijuana organizations. These conditions include:
- Products meant for sale to other medical marijuana organizations must have specified concentrations of total Tetrahydrocannabinol (THC) and total Cannabidiol (CBD).
- The product to be sold must have a consistent cannabinoid profile. The marijuana manufacturer must specify the concentration of cannabinoids in any marijuana product, which must be ascertained by an approved laboratory. These cannabinoids include:
- Tetrahydrocannabinol (THC)
- Tetrahydrocannabinol acid (THCA)
- Tetrahydrocannabivarin (THCV)
- Cannabidiol (CBD)
- Cannabidiolic acid (CBDA)
- Cannabidivarine (CBDV)
- Cannabinol (CBN)
- Cannabigerol (CBG)
- Cannabichromene (CBC)
- Any other cannabinoid that has a concentration above 0.1% of the marijuana product’s content
How Does Pennsylvania Classify Marijuana Manufacturing Licenses?
The medical marijuana grower/processor permit awarded to marijuana manufacturers in Pennsylvania covers every aspect and type of medical marijuana product manufacturing in the state. All aspects of the medical marijuana manufacturing processes by a marijuana organization can happen in a single facility. The manufacturing company only needs to comply with manufacturing conditions approved by the Pennsylvania Department of Agriculture and Pennsylvania Department of Health. These conditions stated in Title 28, Chapter 1151.27 of the Pennsylvania Code include:
- The processing of the raw marijuana plant to finished products must be done on food-grade stainless steel benches or tables.
- The medical marijuana manufacturing organization must have a separate and secure section for the temporary storage of:
- Immature medical marijuana plants
- Mature medical marijuana plants
- Medical marijuana products
- Waste medical marijuana plants and marijuana products awaiting disposal
- The organization must maintain proper sanitation.
- The organization must maintain proper rodent, bird, and pest exclusion practices.
- The medical marijuana manufacturer should not add any active ingredient or substance that can alter the:
- The dosage level of the medical marijuana or medical marijuana product
- The appearance of medical marijuana
- The smell of medical marijuana
- Taste of medical marijuana
- Effect of medical marijuana
- Weight of medical marijuana
A medical marijuana manufacturer that needs to include an active ingredient in marijuana during production must first obtain the prior written approval of the Pennsylvania Department of Health.
What are the Different Types of Cannabis Manufacturing Licenses in Pennsylvania?
Pennsylvania has only one type of cannabis manufacturing license. This is the medical marijuana grower/processor permit. Anyone holding it may engage in medical marijuana manufacturing legally.
Does Pennsylvania Require a Separate License to Manufacture Edibles?
The only license required for manufacturing medical marijuana products, including cannabis edibles in Pennsylvania, is the medical marijuana grower/processor license. A medical marijuana manufacturer is not required to obtain any other additional license to be able to produce any form of medical marijuana product in the state. However, Title 28, Chapter 1151.34 of the Pennsylvania Code specifies conditions that licensed medical marijuana manufacturers in Pennsylvania must meet. These include:
- The medical marijuana manufacturer shall package and label every form of medical marijuana product that is prepared for sale. They must ensure that the original seal of the package is not broken before the sale of the product
- A medical marijuana manufacturer must ensure that the package of each of their medical marijuana product:
- Allows minimum exposure to oxygen
- Is child-resistant
- Is tamper-proof
- Is light-resistant or opaque, or both
- A medical marijuana manufacturing organization must obtain written approval from the Pennsylvania Department of Health on the content of the label to be affixed to each medical marijuana product package. The labels on each of the medical marijuana product packages must:
- Be legible and easily readable.
- Be made of materials that are weather-resistant and tamper-resistant.
- Be placed conspicuously on the package.
- Bear the name, address, and the medical marijuana grower/processor permit number allotted to the cannabis manufacturer.
- Contain the form, quantity, and weight of medical marijuana to be put in the package.
- Contain the batch number and other identifiers specifying the harvest batch or process batch to which the medical marijuana product in the package belongs.
- Contain the date the medical marijuana product was packaged.
- Contain the employee identification number of the worker that packaged the medical marijuana product.
- Contain the employee identification number of the employee shipping the package, in case the employee is different from the person that packaged the product
- Bear the name and address of the medical marijuana dispensary in which the product is to be sold
- Contain the expiry date of the medical marijuana product.
- Contain instructions on the proper storage of the product.
- Contain the prescribed warning statement; “This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant’s pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.”
- Include a warning that the medical marijuana product in the package must be retained in the original product container in which it was sold until it is exhausted.
- Include a warning that unauthorized use of the content by the purchaser is classified as an unlawful act and may attract criminal penalties.
There are other regulations by the Pennsylvania Department of Health on the manufacturing of edible medical marijuana products. The labeling of their medical marijuana products must not:
- Bear any similarity with the trademark, product-specialized packaging, or other characteristics of any commercially available food or beverage.
- Bear any statement or design that may give an impression that the package contains any other thing aside from medical marijuana.
- Bear any badge of the government or agency of government such as seal, flag, crest, coat of arms of the state, county, municipality, etc. It must not in any way give a misleading impression that the medical marijuana product has been endorsed, manufactured, or approved by a government-related agency.
- Bear any feature that can make the product package attractive to children. These include images, color schemes, cartoons, and graphic features that can be attractive to children.
How to Get a Cannabis Manufacturing License in Pennsylvania
The Pennsylvania Department of Health is responsible for issuing the medical marijuana grower/processor permits in Pennsylvania. The department determines when to absorb new medical marijuana manufacturers in the state. Since the legalization of medical marijuana in Pennsylvania in 2016, the department has opened up the grower/processor permit application twice. The first phase was called the phase I grower/processor application, while the second phase, phase II grower/processor application. The phase II grower/processor application opened on 5th April 2018 and closed on 17th May 2018. Application for grower/processor permit in Pennsylvania is still closed until the department announces another phase of applications.
The typical application procedure for grower/processor permits in Pennsylvania involves the following:
- The completion of a Medical Marijuana Grower/Processor Permit Application Form, which is usually accessible from the Pennsylvania Department of Health’s website anytime the application is open
- The completion of the attachment pages and checklist, which is usually attached to the grower/processor application form
- The submission of a redacted version of the application documents as provided with the online application form
- The payment of some required fees, such as:
- Initial application fee
- Initial permit fee
Applicable fees can be paid via checks or money orders written in favor of the “Commonwealth of Pennsylvania”. Applicants should mail completed applications to:
Office of Medical Marijuana
Department of Health
Room 628, Health and Welfare Building
625 Forster Street
Harrisburg, PA 17120
How Much Does a Cannabis Manufacturing License Cost in Pennsylvania?
The standard fees for cannabis manufacturing license in Pennsylvania include:
- An initial deposit of $10,000, which is non-refundable
- A permit fee of $200,000, which is refundable in case an application is denied
Applicants for a grower/processor license also need to show proof that they have up to $2,000,000 capital requirement, $500,000 of which must be a deposit in a financial institution. The cost for the renewal of the grower/processor license in Pennsylvania is $10,000. Applicants applying for permit renewal are required to remit this amount while submitting their application. In case the permit renewal is not granted, the amount will be refunded to the applicant.