CHEAC Summary. CDPH Emergency Cannabis Regulations

Transcription

1 CHEAC Summary CDPH Emergency Cannabis Regulatins Manufacturing The Califrnia Department f Public Health (CDPH) has released emergency regulatins fcused n the medicinal and adult-use manufacturing f cannabis prducts thrughut Califrnia. We encurage members t read the entire emergency regulatins dcument released by CDPH; hwever, a summary f the mst relevant aspects is prvided belw. Key Changes Made in Regulatins Cannabis prduct universal label has been changed: CHEAC) (Requested change by Manufacturing licensees may nt manufacture any ther prducts n their premises nr may they emply anyne under the age f 21. (Requested change by CHEAC) Prhibits the sale f any edible cannabis prduct that CDPH determines is attractive t children. Prhibits the sale f any edible cannabis prduct in the shape f a human being, either realistic r caricature, animal, insect, r fruit. Prhibits the sale f any edible cannabis prduct that CDPH determines is easily cnfused with cmmercially available fds. Cannabis infused juices and cannabis infused dried meat prducts are nw allwed t be manufactured. Any edible cannabis prduct that fails lab testing requirements is prhibited frm being remediated r reprcessed and must be destryed. Dairy prducts cntinue t be prhibited except fr cmmercially purchased butter that may be subsequently infused with cannabis and sld as a cannabis prduct. Cannabis prduct infrmatinal panel labeling requirements cncerning pregnant r breastfeeding wmen have been strengthened t warn use may be harmful. Labeling restrictins nw expressly prhibit the use f the terms candy r candies. Allws cannabis prduct labels t nw include health-related statements s lng as it is supprted by the ttality f publicly available scientific evidence, and fr which there is significant scientific agreement. Advertising and marketing f cannabis prducts must meet existing statutry requirements. Allws fr any cannabis prduct in a manufacturer s pssessin prir t January 1, 2018, t enter the market if all f the fllwing are met:

2 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Packaging must be child-resistant Prducts must be labeled with the required gvernment warning Prducts meet applicable THC limits Weights and measures shall be used fr varius cannabis prduct related purpses and must be registered with the cunty sealer. (Suggested clarificatin by CHEAC) Law enfrcement persnnel and state emplyees wh have any respnsibility fr cannabis related enfrcement activities are prhibited frm hlding a license fr cannabis activity. N vlatile slvent extractins may ccur in residential areas. Allws licensees t apply fr licensing relief by state regulatry agencies during a disaster. Operatinal definitins (pages 1-8) These include: Adulteratin (defined in statute), cannabis prduct, edible cannabis prduct, envirnmental pathgen, infusin, labeling, manufacture, package r packaging, preventive cntrls, and prduct identity. New definitins include cannabis cncentrates, serving size, and adding that n edible prduct may be called a candy r candies. License Required (page 11) Creatin f tw license types: M-license fr thse manufacturers making cannabis prducts fr sale in the medicinal-use market. A-license fr thse manufacturers making cannabis prducts fr sale in the adult-use market. Requires a manufacturing license fr each separate premises where cannabis prducts will be manufactured. Persnnel Prhibited frm Hlding Licenses (pages 11-12) New regulatins are included delineating persnnel that are prhibited frm hlding manufacturing licenses including: Any persn hlding ffice in r emplyed by any agency f the State r any f its plitical divisins when the duties f that persn have t d with the enfrcement f the Act r any ther penal prvisins f law prhibiting r regulating the sale, use, pssessin, transprt, distributin, testing, manufacturing, r cultivatin f cannabis gds. Page 2 f 10

3 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Law enfrcement including anyne emplyed by the State Department f Justice, any district attrney s ffice emplyees, any city attrney s ffice emplyees, any lcal sheriff s ffice emplyees r any lcal plice department emplyees. All f the afrementined emplyees are als prhibited frm having any wnership interest in any business t be perated under a cannabis license. Manufacturing License Categries and Types (pages 12-13) Type P entities that nly package r repackage medical cannabis prducts r label r relabel the cannabis prduct cntainer. Type N manufacturers that prduce edible prducts r tpical prducts using infusin prcesses, r ther types f medical cannabis prducts ther than extracts r cncentrates. Type 7 (vlatile slvent extractins) and Type 6 (mechanical methds r nnvlatile slvent extractins) Temprary Licenses (pages 14-15) Allws fr the issuance f a temprary license. Applicants must submit a CDPH applicatin, a cpy f a lcal license, permit, r ther authrizatin issued by the lcal jurisdictin where the cmmercial cannabis business perates. Temprary licenses are perative fr 120 days frm their effective date and may be extended fr additinal 90-day perids if the temprary license hlder submits a cmplete licensure applicatin t CDPH. Annual Applicatin Requirements (pages 15-21) T apply t the State fr licensure, applicant must submit a cmpleted CDPH applicatin frm including, amng thers, the fllwing attestatins: Cmmercial cannabis business is perating in cmpliance with all lcal rdinances. Prpsed lcatin is nt within a 600-ft radius f the perimeter f a schl, daycare center, r yuth center (r is in cmpliance with a lcal rdinance specifying a different radius). Applicants als must submit delineated business infrmatin, wner infrmatin, and manufacturing premises and peratins infrmatin. Limited Waiver f Svereign Immunity (pages 21-23) Any applicant r licensee that falls within the scpe f a svereign immunity must cnduct all cmmercial cannabis activity in full cmpliance with the state laws and regulatins gverning cmmercial cannabis activity, including all enfrcement prvisins. Must allw access as required by state statute r regulatin t persns r entities charged with duties under state law r regulatins gverning cmmercial cannabis activity. Page 3 f 10

4 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Applicatin and License Fees (page 24-25) Requires a nnrefundable applicatin fee f $1,000. Fees range frm $2,000 t $75,000 a year based n grss annual revenues. Pririty License Issuance (page 26) Qualified applicants shall be given pririty in license issuance if the applicant can demnstrate the cmmercial cannabis business was in peratin under the Cmpassinate Use Act as f September 1, Denial f License (page 27) CDPH must deny an applicatin fr new r renewal license if the prpsed manufacturing peratin r premises wuld vilate the applicable lcal rdinance. License Cnstraints (pages 31-32) N applicant fr manufacturing may hld a testing license. Licensees are nt allwed t manufacture, prepare, package, r label any prducts ther than cannabis prducts at the licensed premises. Licensees are prhibited frm emplying any individual under 21 years f age. Disaster Relief (pages 34-35) Allws fr licensees t request relief frm state licensing entities due t disaster, including fire, fld, strm, tidal wave, earthquake, r similar public calamity. Safety and Security (pages 36-38) Every licensee must have in place a Security Plan and have a cmplete digital vide surveillance system in place. Extractins (pages 39-41) Vlatile slvent extractins may nt ccur in residential areas. Extractin peratins must be apprved by the lcal fire cde fficial and be perated in accrdance with Cal/OSHA standards and any ther relevant state r lcal requirements. Gd Manufacturing Practices (pages 41-51) Written Persnnel prcedures must include: Disease Cntrl Cleanliness including thrugh hand washing, glves, hairnets, preventin f crss cntaminatin Written Premises prcedures must include: Page 4 f 10

5 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Kept in cnditin that prevents cntaminatin f cmpnents and cannabis prducts, including prper strage f equipment, prvisin and maintenance f waste treatment systems Facility Cnstructin & Design requirements include: Adequate precautins t reduce ptential fr allergen crss-cntact and fr cntaminatin f cannabis prducts Prtectin fr prductin ingredients Adequate lighting fr handwashing areas, amng thers Adequate ventilatin r cntrl equipment Written Sanitary peratins must include: Ensure physical facilities n premises are maintained in a manner t prevent cannabis prducts frm becming adulterated Ensure that cleaning and sanitatin f utensils and equipment prtect against allergen crss-cntact and cntaminatin f cannabis prducts r prduct cmpnents Sanitary Facilities and cntrls shuld cver: Water supply, plumbing, sewage dispsal, tilet facilities, hand washing facilities, and rubbish dispsal Equipment & Utensils shuld be designed t prtect against adulteratin and allergen crss-cntact r frm cntaminatin by any surce Prductin and Prcess Cntrls (pages 51-67) Apprpriate quality cntrl peratins must be emplyed t ensure cannabis prducts are suitable fr human cnsumptin r use. Licensees must establish and implement written plicies and prcedures t ensure the quality f raw materials and ingredients. Establish & fllw written manufacturing peratin prcedures. Cnduct and prepare a written hazard analysis, including bilgical, chemical, and physical hazards. Identify and implement written preventive cntrls t ensure manufactured cannabis prducts are nt adulterated r misbranded. Establish and implement written prcedures fr equipment and machinery. Establish and fllw a written master manufacturing prtcl fr each unique frmulatin f cannabis prduct manufactured, and fr each batch size. Page 5 f 10

6 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Prepare written batch prductin recrds fr when every cannabis prduct batch is manufactured. Establish and implement written prcedures n prduct cmplaints. Establish and implement written prcedures fr recalling cannabis prducts. Recalled prducts must be quarantined and then must be dispsed f apprpriately. Licensee must ntify CDPH f any recall within 24 hurs. Special Prcessing Requirements (pages 67-68) Allws fr the manufacture f cannabis infused juice and cannabis-infused dried meat prducts. Other Respnsibilities (pages 69-75) Licensees must establish and maintain written standard perating prcedures. Any weighing devices used by a licensee must be apprved, tested, sealed, and registered with the cunty sealer. Licensees must implement a training prgram cvering tpics including health and safety hazards, emergency prcedures, quality cntrl prcedures, hazard analysis and cntrl prcedures, and cleaning and maintenance requirements. Any licensee prducing edible cannabis prducts must have all persnnel wh prepare, handle r package edible prducts successfully cmplete an accredited fd handler curse within 90 days f emplyment & then every three years. Licensees must establish and implement written inventry cntrl plan. Licensees must dispse f all waste in accrdance with applicable state and lcal laws and regulatins. Any waste that cntains cannabis in any frm must be dispsed f in a secured waste receptacle r secured area n the licensed premises. N cannabis prduct shall be dispsed f in its packaging. All cannabis prducts must be made unrecgnizable and unusable prir t dispsal. Cannabis Prduct Standards (pages 76-80) Licensees are prhibited frm infusing alchlic beverages. Prhibitive additives include nictine and caffeine, but des nt apply when prducts cntain naturally ccurring caffeine (eg: cffee, tea, r chclate). Page 6 f 10

7 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Prhibits the sale f dairy prducts except fr butter, purchased frm a licensed milk prducts plant r retail lcatin that is infused with cannabis and sld as a cannabis prduct. Prhibits the sale f any cannabis prduct that CDPH determines is attractive t children. Prhibits the sale f any cannabis prduct CDPH determines is easily cnfused with cmmercially available fds withut cannabis. Prhibits the sale f any cannabis prduct in the shape f a human being, either realistic r caricature, animal, insect, r fruit. Licensees are prhibited frm applying cannabinid cncentrate r extract t cmmercially available candy r snack fd items. Edible cannabis prducts are limited t ten milligrams f THC per serving. Limits edible cannabis prducts t n mre than 100 milligrams f THC per package. Edible prducts that cnsist f mre than a single serving must either be: Scred, delineated, r therwise marked t indicate ne serving Packaged in such a manner that a single serving is readily identifiable Each serving f an edible cannabis prduct in a multi-serving package must be hmgenized t cntain the same cncentratin f THC. Any cannabis prduct that is nt edible and manufactured fr the adult-use market may nt cntain mre than 1,000 milligrams f THC per package. Any cannabis prduct that is nt edible and manufactured fr the medicinal market may nt cntain mre than 2,000 milligrams f THC per package. Tpical cannabis prducts may nly cntain ingredients permitted fr csmetic manufacturing. Any cannabis prduct batch that fails a lab test requirement is adulterated and may be embarged. Failed prduct batches must be destryed unless remediatin r reprcessing is apprved by CDPH. Edible prducts that fail lab testing requirements shall nt be remediated r reprcessed and must be destryed. Labeling and Packaging Requirements (pages 81-87) Page 7 f 10

8 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 All infrmatin required t be listed n the label must be in English. All required label infrmatin must be lcated n the utside cntainer r wrapper f the finished prduct t be sld at a retailer. Primary panel labeling requirements include identity f the prduct, the cannabis universal prduct symbl, the net weight r vlume f the cntents, the THC and CBD cntent fr the package in its entirety. Fr edible cannabis prducts, the label must als cntain the wrds cannabisinfused abve the identity f the prduct and the THC and CBD cntent per serving. Labels must include the manufacturer s name and cntact infrmatin, date f manufacture, an expiratin date, the UID r batch number, and the fllwing statement: GOVERNMENT WARNING: THIS PRODUCT CONTAINS CANNABIS, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. CANNABIS PRODUCTS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. THE INTOXICATING EFFECTS OF CANNABIS PRODUCTS MAY BE DELAYED UP TO TWO HOURS. CANNABIS USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF CANNABIS PRODUCTS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION. If the prduct is intended fr sale in the medicinal-use market, the statement Fr Medicinal Use Only must als be included. All prduct ingredients in descending rder must be included n the label. If the prduct is edible and cntains an ingredient, flavring, clring r an incidental additive that bears r cntains a majr fd allergen, the wrd cntains, fllwed by a list f the applicable majr fd allergens must be included n the label. If the prduct is edible, the label must als cntain the amunt in grams f sdium, sugar, carbhydrates, and ttal fat per serving. Labeling restrictins include: Cntent that is r designed t be attractive t individuals under the age f 21 (cartns, images, characters, r phrases ppularly used t advertise t children, any imitatin f candy packaging r labeling, claims f health benefits r ther physical benefits. All prducts must be marked, stamped r therwise imprinted with the cannabis universal prduct symbl. Nt including the terms candy r candies. May nt include any health-related statement that is untrue r misleading. Page 8 f 10

9 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Any health-related statement must be supprted by the ttality f publicly available scientific evidence, and fr which there is significant scientific agreement. Manufacturers may include infrmatin n the ptential effects f the cannabis prduct if the manufacturer has substantiatin that the infrmatin is truthful and nt misleading. The primary panel f a cannabis prduct must be marked, stamped, r therwise imprinted with the universal cannabis prduct symbl: Packaging must prtect frm cntaminatin, tamper-evident (cannt be pened withut bvius destructin f the seal), child-resistant (significantly difficult fr children under five years f age t pen), and may nt imitate any package used fr prducts typically marketed t children. If the prduct is edible, the package must be paque. If the package cntains mre than ne serving f cannabis prduct, the package must be re-sealable s that child-resistance is maintained thrughut the life f the package. Cmpliance (pages 88-95) Licensees must keep the fllwing dcuments available n the premises at all times and must make available t CDPH and any enfrcement agency upn request: Valid state license Any ther valid license issued by a state cannabis licensing agency Valid license, permit, r ther apprval issued by the lcal jurisdictin A premises diagram Current standard perating prcedures Shipping manifests Emplyee recrds Licensees must enter all cmmercial cannabis activities int the track-and-trace system within 24 hurs f ccurrence. Places requirements n licensees track-and-trace reprting requirements, within 24 hurs, including receipt f cannabis material, transfer r receipt f cannabis prducts fr further manufacturing, and all changes in the dispsitin f cannabis r cannabis prducts. Page 9 f 10

10 CHEAC Summary CDPH Regulatins (Manufacturing) Nvember 21, 2017 Requires licensees t ensure that all advertising and marketing f its cannabis prducts meet the requirements as defined in statute. Allws the Department & its inspectrs r agents t cnduct n-site inspectins prir t issuing a license r renewing a license. Allws the Department and its inspectrs r agents free access at reasnable times t manufacturing premises, strage areas, recrds, prductin prcesses, labeling and packaging prcesses including all pertinent equipment, raw material, finished and unfinished materials, cntainers, packaging, and labeling. Allws CDPH t cnduct investigatins cncerning the adulteratin, misbranding, false r misleading advertising r marketing, r unlicensed prductin f any cannabis prduct including the ability t enter and inspect any place where any cannabis prduct is suspected f being manufactured r held in vilatin f the Act r regulatins. Transitinal Perid (pages 96-97) Allws any cannabis prduct that is in pssessin f a manufacturer prir t January 1, 2018, t be entered int the cmmercial cannabis market if the fllwing cnditins are met: The prduct is packaged in child-resistant packaging. The prduct cntains the gvernment warning. A sticker with the required statement placed n the utside f the package will be sufficient. The prduct meets applicable THC limits. The prduct cntains the amunt f THC, and, if applicable, CBD per serving and per package. A sticker with the required infrmatin placed n the utside f the package will be sufficient. Page 10 f 10