Federal Regulation of Controlled Substances 5 PDF

Federal Regulation of Controlled Substances 5 February 28, 2024 Learning Objectives Describe regulations for the disposal of controlled substances Describe drug take back programs Describe inventory requirements Describe storage requirements for controlled substances in pharmacies Describe steps you...

Federal Regulation of Controlled Substances 5 February 28, 2024 Learning Objectives Describe regulations for the disposal of controlled substances Describe drug take back programs Describe inventory requirements Describe storage requirements for controlled substances in pharmacies Describe steps you should take if you discover controlled substances are lost or stolen List the conditions that provide for the federal investigation of pharmaceutical theft List the types of controlled substance records registrants are required to maintain Describe how to file prescriptions Describe legal pharmacy employment practices Describe methamphetamine anti-proliferation legislation 2 Describe regulations for the disposal of controlled substances A pharmacy may transfer controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances. The pharmacy should contact the local DEA Diversion Field Office for an updated list of DEA registered reverse distributors. When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the pharmacy. When schedules III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred. 3 Describe regulations for the disposal of controlled substances The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form 41 to the DEA when the controlled substances have been destroyed. What about every day hospital wastage? 4 Describe drug take back programs 5 https://www.deadiversion.usdoj.gov/drug_disposal/takeback/takeback.html#:~:text=The%20next%20National%20Prescription%20Drug,potential%20for%20abuse%20of%20medications. 6 https://www.dea.gov/sites/default/files/2023-11/NTBI%2025%20finals.pdf 7 https://www.dea.gov/sites/default/files/2023-11/NTBI%2025%20finals.pdf Describe drug take back programs Started in September 2010 and was meant to be temporary and stop in September 2014. Was to be replaced by the Secure and Responsible Drug Disposal Act of 2010 allowing ultimate users to deliver unused pharmaceutical controlled substances to appropriate entities for disposal in a safe and effective manner consistent with effective controls against diversion DTBDs are still conducted every fall and spring through local law enforcement. 8 Describe drug take back programs Year-round disposal locations are also available: https://apps2.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution =e3s1 9 Describe inventory requirements When a registrant first engages in practice or starts a business, and every 2 years thereafter, a complete and accurate inventory of stocks of controlled substances must be taken. Inventories do not get sent to the DEA; they stay in the pharmacy for 2 years. All sealed containers should be counted. For opened containers, the following should be performed:  Exact count of all schedule II substances  For schedule III-V, an estimated count or measure is permitted unless the container holds greater than 1000 tablets or capsules, in which case an exact count must be made if the container is opened. 10 Describe inventory requirements The inventory is to include ALL controlled substances “on hand” the day the inventory is taken, including controlled substances filled for a patient but not yet picked up. The biennial inventory may be taken on any date that is within 2 years of the previous inventory. Registrants must take a physical inventory of any drug newly added to a schedule or switching schedules, effective that day. Perpetual inventories are not required by CSA. 11 Describe inventory requirements The finished inventory document should include:  Name, address, and DEA registration number of the registrant  Date and time inventory is taken  Signature of the person taking the inventory  An indication that the inventory is maintained for 2 years on site  An indication that inventory records and all other records for CIIs are filed separately from other records  Name of the controlled substance  Dosage form  Strength or concentration per dosage unit  Amount of dosage units/volume per commercial container  Number of commercial containers 12 Describe inventory requirements For controlled substances kept for compounding, the records should contain:  Name of the controlled substance  The total quantity to the nearest metric weight or the total number of units of finished form  The reason the controlled substance is maintained by the registrant and whether the substance is capable of use in the manufacture of any controlled substance in finished form. 13 Describe storage requirements for controlled substances in pharmacies CIIs-CVs must be stored in a securely locked, substantially constructed cabinet or be distributed throughout the inventory of noncontrolled drugs in a manner which will obstruct theft or diversion of controlled substances, or a combination of these methods 14 Describe steps you should take if you discover controlled substances are lost or stolen According to the CSA, if you notice a theft of significant loss of any controlled substances, you MUST do the following three things:  Notify your nearest DEA division office within one business day of the discovery of the loss or theft  Notify the police  Complete DEA Form 106 and submit it to the DEA 15 Describe steps you should take if you discover controlled substances are lost or stolen What constitutes a significant loss? The following factors should be taken into consideration:  The quantity lost in relation to the type of business  The specific controlled substances lost and whether they are likely candidates for diversion  Whether the loss can be attributed to individuals or unique activities  Whether the losses are random or fit a pattern  Local trends 16 Describe steps you should take if you discover controlled substances are lost or stolen The DEA Form 106 is completed online or on paper and requests the following information:  DEA number of your pharmacy  Last name of registrant OR business name that was registered  Details of the theft or loss (date and place, burglary or armed robbery, were police contacted, etc.)  NDCs of controlled substances lost/stolen and the quantity lost/stolen  Name and title of person filing the report 17 Describe steps you should take if you discover controlled substances are lost or stolen When all or part of a shipment disappears, or never reaches its intended destination, the supplier is responsible for reporting the in-transit loss of controlled substances to the DEA. The pharmacy is responsible for reporting any loss of controlled substances after a pharmacist has signed for or taken custody of a shipment. Breakage, damage or spillage does not constitute a “loss of controlled substances”. In such situations, any recoverable controlled substances must be disposed of according to DEA requirements including the submission of a DEA Form 41. 18 List the conditions that provide for the federal investigation of pharmaceutical theft  Value of the controlled substances is more than $500  A registrant or other person is killed or suffers significant bodily injury during the commission of the robbery or theft of a controlled substance  Interstate or foreign commerce is involved in planning or executing the crime 19 List the types of controlled substance records registrants are required to maintain 1. 2. 3. 4. Executed and unexecuted official order forms (DEA Form 222) or the electronic equivalent Power of Attorney authorization to sign order forms Receipts and/or invoices for schedules III, IV, and V controlled substances All inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or close of business 5. Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors) 6. Records of controlled substances dispensed (i.e., prescriptions, schedule V logbook) 7. Reports of Theft or Significant Loss (DEA Form 106), if applicable 8. Inventory of Drugs Surrendered for Disposal (DEA Form 41), if applicable 9. Records of transfers of controlled substances between pharmacies 10. DEA registration certificate (DEA Form 223) 11. Self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine Epidemic Act of 2005 20 List the types of controlled substance records registrants are required to maintain ALL CONTROLLED SUBSTANCE RECORDS MUST BE MAINTAINED FOR 2 YEARS Records of all CIIs must be maintained separately from all other pharmacy records. Records of CIII-CV should be maintained separately from all other records, but they need not be separate, provided that they are readily retrievable from other records. out  Records kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated from all other records in a reasonable time, and/or  Records kept in such a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records. 21 Describe how to file prescriptions (KNOW THESE!!) Controlled substance records may be filed in one of two ways:  In 3 separate files One file for schedule II One file for schedule III-V One file for all non-controlled  In 2 separate files One file for schedule II One file for schedule III-V and non-controlled 22 Describe how to file prescriptions If using method  for prescriptions, the law previously required that all schedule III-V prescriptions be stamped with the letter “C” in red ink, not less than one inch high, in the lower right hand corner of the prescription. Pursuant to regulations enacted March 28, 1997, however, the red “C” requirement was waived for pharmacies that use an electronic recordkeeping system for prescriptions that permits identification by prescription number and retrieval of original documents by the prescriber’s name, patient’s name, drug dispensed, and date filled. The red “C” may still be used if it is preferred. 23 Describe legal pharmacy employment practices If you work in a DEA-registered pharmacy you may not hire anyone who:  Has been convicted of a felony related to controlled substances OR  Has had an application for a DEA registration denied, revoked or suspended resulting from investigation of their handling of controlled substances 24 Describe legal pharmacy employment practices If you desire to hire an employee that meets one of the above descriptions, you will need to request a waiver from the DEA to hire this person. Such a waiver should not be considered unless there is valid reason to believe that diversion is unlikely to occur. The DEA will consider the following factors:  A detailed description of the nature and extent of the applicant’s past controlled substance violations  Activities of the applicant since the violation  Current status of the applicant’s state licensure (if applicable)  Extent of the applicant’s proposed access to controlled substances  Registrant’s proposed physical and professional safeguards to prevent diversion by the applicant, if employed  Status of employing registrant regarding handling of controlled substances  Other pertinent information uncovered by the DEA in its investigation of the applicant’s or registrant’s handling of controlled substances 25 Describe methamphetamine anti-proliferation legislation THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005 (COMBAT METH ACT) The Combat Meth Act is enforced by the DEA. Provisions for non-prescription sales of methamphetamine precursors include: sale  When offering products containing these drugs for sale, the seller must place the product so that purchasers do NOT have direct access to the product before the is made. This may be behind the counter or in a locked cabinet that is located in an area that is not accessible to the purchaser.  The seller must directly transfer the product to the purchaser  The seller must maintain a written or electronic log of such sales that identifies: 1. 2. 3. 4. The name of the purchased products The quantity sold The name and address of the purchaser The date and time of sale 26 Describe methamphetamine anti-proliferation legislation THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005 (COMBAT METH ACT)  In order to complete a transaction that requires such a log entry, the purchaser must a photo ID issued by the state or the federal government and must sign the log. present  and  are not required if the customer purchases a single sales package that contains 60 mg or less of pseudoephedrine  The seller must determine that the name entered in the log by the purchaser corresponds to the name provided on the photo ID and that the date and time are correct.  The log must have a notice displayed that indicates that entering false statements or misrepresentations in the log may subject the purchaser to criminal penalties. The notice must also indicate the maximum fine and term of imprisonment related to such a penalty. 27 Describe methamphetamine anti-proliferation legislation THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005 (COMBAT METH ACT)  Must keep log for at least 2 years after the last date of entry  Individuals who deal directly with purchasers must be trained by their employer. The employer must submit written evidence to the DEA that these employees have been trained to carry out these requirements.  No purchaser may lawfully purchase at retail more than 9 grams of precursors within any 30 day period or more than 3.6 grams in any single transaction.  All non-liquid dosage forms of these products must be packaged in blister or unit dose packaging with not more than 2 doses per blister pack 28 Describe methamphetamine anti-proliferation legislation THE METHAMPHETAMINE PRODUCTION PREVENTION ACT OF 2008 Intent is to facilitate and encourage but NOT REQUIRE electronic logbooks so that information may be shared among pharmacies and law enforcement. Allows for federal grants to states to set up such systems Know the different purposes of all 4 meth acts, and details of the combat meth act 29 Describe methamphetamine anti-proliferation legislation MISSISSIPPI REGULATORY CHANGES SB 2119 allows for OTC sales of pseudoephedrine (PSE) starting January 1, 2022 Previously prescription Compliance limits: 18 years or older (stricter than combat meth act) 3.6 grams per day 7.2 grams per 30 days (stricter than combat meth act) If selling OTC, must participate in National Precursor Log Exchange (NPLEx) which provides real-time PSE electronic tracking in accordance with the combat meth act. 30