Wyoming Controlled Substances Act of 1971

1. Wyoming Controlled Substances Act of 1971 Rules and Regulations Concurrent Jurisdiction Drug Enforcement Administration (�DEA�), parallel counterpart agency in Wyoming; the Board of Pharmacy. DEA�s scope of responsibility is broader large-scale trafficking in substances of abuse such as cocaine, heroin and marijuana. Board of Pharmacy is more likely to be interested in individual Wyoming practitioners than DEA.

2. Wyoming CSA virtually the same as the Federal Act Not true in all states. This two-jurisdiction approach may pose a problem When two laws apply to the same subject, whose law must be applied? When the state and federal laws are in conflict, that is when both laws cannot be obeyed, the federal provision will control. If the state�s law is without conflict but simply stricter, then it will control.

3. Conflict Example: a state places a controlled substance in Schedule II the federal designation is Schedule 3 practitioners are obliged to follow the state law.

4. Criteria for Regulation: Scheduling Based on their medical value, potential for abuse, relative propensity for addiction and inherent danger. Procedural note; scheduling may occur in one of three ways. Wyoming legislature may schedule (or delete) a substance. Commissioner of Drugs and Substances Control with the advice of the Advisory Board. Criteria include: the presence of medical value, relative safety, potential for abuse, and relative propensity to cause dependence. Automatic adoption of a federal scheduling action.

5. SCHEDULE I. The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the US. There is a lack of accepted safety for use of the drug or other substance under medical supervision. Examples: marijuana, LSD, peyote, MDMA (�ecstasy�), precursor substances and many more.

6. SCHEDULE II. The drug or other substance has a high potential for abuse. The drug or other substance has a currently accepted medical use in treatment in the US or a currently accepted medical use with severe restrictions. Abuse of the drug or other substances may lead to severe psychological or physical dependence. Examples: cocaine, morphine, meperidine, oxycodone, d-amphetamine, and most oral and injectible barbiturates.

7. SCHEDULE III. The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. The drug or other substance has a currently accepted medical use in treatment in the US. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence. Examples: acetaminophen w/codeine, aspirin w/codeine, hydrocodone combinations, and paregoric.

8. SCHEDULE IV. The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III. The drug or other substance has a currently accepted medical use in treatment in the US. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. Examples: benzodiazepines, phenobarb, chloral hydrate, butorphanol.

9. SCHEDULE V. The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV. The drug or other substance has a currently accepted medical use in treatment in the US. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV. Examples: Codeine containing cough suppressants and anti-diarrheals, diphenoxylate combinations, and mixtures containing paregoric.

10. Registration Each of the following activities requires registration: Manufacturing Distributing Dispensing Research Chemical analysis The federal government requires registration of methadone clinics and importing and exporting of controlled substances.

11. The Wyoming Board of Pharmacy administers the registration process �Public interest� approach the applicant�s ability to prevent diversion, its compliance with applicable laws, any convictions relating to controlled substances, past experience, and �any other factors relevant� Board may deny applications/renewals not in the �public interest.�

12. DEA number allows the �registrant� to order, possess, and utilize controlled substances according to the activity registered. The number consists of two letters followed by seven digits. The lead letter is a designation of the primary activity that the registration permits. The second letter is generally the first letter of the name of the registrant.

13. WY Section 35-7-1026 provides for suspension or revocation untruthfulness in the application process, conviction of a felony or misdemeanor relating to controlled substances, willful violations, had a federal registration suspended, or has failed to provide adequate security. adequate notice and opportunity for a hearing must be provided unless imminent danger to public health or safety� exists.

14. Annual renewal per Wyoming law DEA allows all dispensers to obtain a three-year registration while requiring manufacturers and distributors to renew annually. Hospital pharmacies are permitted to use the hospital�s registration number. Wyoming law permits physicians, dentists, veterinarians, physician assistants, nurse practitioners, and podiatrists to prescribe controlled substances.

15. Dual Registration (dispenser and distributor) Pharmacists may sell small quantities of controlled substances to colleagues who are experiencing a temporary shortage (DEA 222 completed when appropriate), and the total amount transferred does not exceed 5% of the total controlled substance units dispensed in one year. If the 5% threshold is exceeded the pharmacy may be required to register as a distributor, etc. Note the similar concerns under the recent amendment to the FD&C Act that exempts routine compounding from being characterized as manufacturing. If the compounding were something other than routine the products would be subject to the �new drug�, �adulteration� and �misbranding� provisions.

16. Paper Trail Records must be maintained in a �readily retrievable� fashion Under federal and Wyoming law, records must be kept on file at the place of registration for 2 years. The DEA has handed down severe penalties for seemingly minor and technical infractions without even the slightest suggestion of diversion or bad faith.

17. Records of Receipt The law requires distinguishing CII�s from other controls. The official order blank is the DEA 222 - required for purchasing CII�s. A three-part form Must be executed deliberately Changes to specific items are not acceptable. The signor may be either the individual that signed the DEA application for registration or an individual that has been given �power of attorney� to do so. For C-III, IV and V�s the regulations require the invoice marked with the date of receipt and the initials of the recipient for audit purposes.

18. Records of Disbursement Prescriptions Inpatient Medication Orders Outside sales Returns and Destruction (Outdates, etc) Unexplained loss and theft

19. Inventories Under Federal law, a physical inventory of all controlled substances at the commencement of business and every two years following. Wyoming sets the date on May 1st of each year. Newly scheduled drugs must be inventoried on the effective date of scheduling.

20. Inventories � 2 Federal regulations establish fairly specific procedures for conducting the inventory An exact count must be made of Schedule II drugs. An estimate may be taken of Schedule III-V drugs unless the commercial package contains more than 1000 tablets or capsules. If the original package contains more than 1000 tablets or capsules then an exact count must be taken. Outdated drugs awaiting return or destruction must also be counted. Like other records, the biennial inventory must be maintained for inspection in a readily retrievable fashion for at least two years from the date the record was made.

21. Prescriptions The �Corresponding Responsibility� Doctrine. �A prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting within the usual course of his professional practice.� Pharmacists that fill prescriptions that they know, or reasonably should know, are not for a legitimate purpose may bear criminal liability under corresponding responsibility rule. DEA guidance in this area is �The Pharmacist�s Guide to Prescription Fraud.�

22. Wyoming Rules and Regulations define two inappropriate CS prescriptions: prescribers may not issue a prescription for a fictitious patient or for �office use�. prescriptions intended for detoxification or for the purpose of continuing a patient�s dependence on a controlled substance Prescriptions for controlled substances require the DEA registration number.

23. Schedule II Prescriptions Generally, Schedule II controlled substances may be dispensed only pursuant to a written prescription that is signed by a qualified practitioner and dated as of the day written. Emergency exceptions exist. Also, in three situations faxed prescriptions will suffice as the original. Schedule II prescriptions are not refillable under any circumstances.

24. Schedule III-V Prescriptions more like non-controlled prescriptions in that they may be written or oral. up to five refills are permitted for CIII-IV�s within 6 months from the date the prescription is written (except Schedule V�s). Partial refills may be made up to the total quantity permitted by the prescription. Like non-controlled substances drugs in CIII-V may be prescribed by fax or electronically.

25. Schedule V Prescriptions With the exception of the refill aspects of C-V controlled substances, the prescription requirements for the legend drugs in this class are generally the same. Note that there are a significant number of non-legend drugs in this schedule that may be dispensed without a prescription.

26. Prescription Drug Tracking Program In 2003 WY law was changed to require a program to track prescribing and dispensing of controlled substances. pharmacies shall submit information to the Board concerning each controlled substance prescription filled. New WY administrative rules are being / have been drafted on this issue. Students may expect the Rules to be in place in early 2004 and obtain a copy from the Board�s website when they are finalized. A notice of the new rules will be placed in the Wyoming State Board of Pharmacy News

27. Labels �Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it is intended.� required for CII-IV (curiously not V) labels under federal law. other federal requirements include the familiar 7-point label: the name, address and telephone number of the pharmacy, the patient�s name, a sequential prescription serial number, the date the medication is dispensed, the prescriber�s name, directions for use any cautionary statements.

28. Labels - 2 effective January 1, 2004 the label must contain a physical description of the tablet or capsule sufficient to identify the contents as being correct. This shall include the shape, color and any identifying codes.

29. Security �effective controls and procedures� Schedules II-V may be stored together in a �securely locked, substantially constructed cabinet� or dispersed throughout the entire inventory in such a way that diversion or theft will be obstructed. the regulations prohibit the employment of any person that will have access to controlled substances �who has had an application for registration denied, or has had his registration revoked, suspended, or limited at any time�. there are security requirements for non-practitioners.