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The National Association of State Controlled Substances Authorities

State Regulatory Developments

JUNE –JULY 2009

Prescriptions/Distribution - Proposed rule of the Department of Health would amend regulations regarding prescriptions and distribution. The proposal would coincide with federal standards to allow practitioners to issue multiple prescriptions for a controlled substance listed in Schedule II authorizing the patient to receive a total of up to a 90-day supply. Comments are due Aug. 9, 2009. Contact: Kenneth Campbell; DOH, Office of the General Counsel; (202-442-5977).

Controlled Substances/Institutional Pharmacies - Proposed rule of the Department of Health, Board of Pharmacy, would amend regulations to clarify requirements for witnessing the destruction of controlled substances in institutional pharmacies. Comments are due June 19, 2009. Contact: Rebecca Poston; DOH, Board of Pharmacy; (850-245-4292).

Drug Distribution - Final rule of the State Board of Pharmacy amends regulations allow nursing homes, long-term care facilities, and hospices to maintain drug distribution records by patient name.

The rule is effective June 4, 2009. Contact: Randall Vaughn; Secretary of State, Professional Licensing Boards Division; (478-207-2440)

Schedule II Prescriptions - Final rule of the Board of Pharmacy amends regulations to specify that no Schedule II prescription order will be filled more than 90 days after the date the order was written. The rule also clarifies the phrase ''prescription drug order.'' The rule is effective May 8, 2009. Contact: Mark Johnston; Board of Pharmacy; (208-334-2536)

Controlled Substances - Emergency rule of the Board of Pharmacy rescinds and readopts regulations regarding controlled substances. The rule temporarily designates tapentadol, a new molecular entity with centrally acting analgesic properties, as a Schedule II controlled substance. The rule also temporarily designates lacosamide as a depressant subject to control and recordkeeping requirements of a Schedule V controlled substance. The rule is effective June 22, 2009. Contact: Terry Witkowski; Board of Pharmacy; (515-281-5279)

Controlled Substances - Proposed rule of the Board of Pharmacy would amend regulations regarding controlled substances. The proposal would establish requirements for issuing multiple prescriptions for the same Schedule II controlled substance for dispensing to the same patient over a period of time not to exceed a 90-day supply. Comments are due July 21, 2009. Contact: Terry Witkowski; Board of Pharmacy; (515-281-5279).

Proposed rule of the Board of Pharmacy would amend regulations regarding universal practice standards and electronic data in pharmacy practice. The proposal would authorize a prescriber to direct the prescriber's agent to transmit to a pharmacy a new prescription drug order that has been manually or electronically signed by the prescriber. The proposal also would require the transmission to identify the prescriber's agent by name and title. Comments are due July 21, 2009. Contact: Terry Witkowski; Board of Pharmacy; (515-281-5279)

Prescription Monitoring Program - Final rule of the Board of Pharmacy adopts regulations regarding the Prescription Monitoring Program. The rule establishes a central database for Schedule II, III, and IV prescriptions containing controlled substances. The rule is effective Aug. 5, 2009. Contact: Terry Witkowski; Board of Pharmacy; (515-281-5279)

Pharmacists - Proposed rule of the Board of Pharmacy would amend regulations regarding pharmacy practice. The proposal would require pharmacists-in-charge to perform a scheduled drug inventory whenever they are newly hired or leave employment, establish requirements for the foreign graduate equivalency examination, and revise requirements for prescription labels. The proposal also would require foreign pharmacy graduates to take an English proficiency examination, set forth requirements for the electronic transmission of prescriptions, and establish procedures relating to the storage and control of drugs administered or dispensed from an institutional drug room. A hearing is scheduled for Sept. 2, 2009, in Topeka. Comments are due Sept. 2, 2009. Contact:

Wholesale Prescription Drug or Device Distributors - Proposed rule of the Department of Health and Mental Hygiene, Board of Pharmacy, would amend regulations regarding the licensing of wholesale prescription drug or device distributors. The proposal would revise the surety bond requirement for applicants for a wholesale distributor permit to $50,000 whose annual gross receipts are under $10 million from sales of prescription drugs and devices. The proposal also would specify that the surety bond remains $100,000 for applicants with annual gross receipts of $10 million or more from sales of prescription drugs and devices. Comments are due July 20, 2009. Contact: Michele Phinney; DHMH, Office of Regulation and Policy Coordination; (410-767-6499)

Volunteer Dispensing of Medications During Emergencies - Final rule of the Department of Health and Senior Services, Division of Community and Public Health, adopts regulations to establish procedures for volunteer dispensing of medications according to the Strategic National Stockpile Plan during a governor-declared state of emergency. The rule is effective Aug. 30, 2009. Contact: Glenda Miller; DHSS, Division of Community and Public Health; (573-751-6080)

Pharmacists/Pharmacies - Proposed rule of the Department of Labor and Industry, Board of Pharmacy, would amend regulations regarding pharmacists and pharmacies. The proposal would revise definitions and provisions concerning the administration of vaccines by pharmacists, prescription requirements, and the transmission of prescriptions by electronic means. The proposal also would address internship requirements, use of pharmacy technicians, automated recordkeeping systems for pharmacies, out-of-state mail service pharmacies, use of emergency drug kits in certain institutional pharmacies, licensure renewal requirements for pharmacy technicians, and unprofessional conduct. A hearing is scheduled for Aug. 6, 2009, in Helena. Comments are due Aug. 14, 2009. Contact: DLI, Board of Pharmacy; (406-841-2371)

Central Prescription Processing - Final rule of the Board of Pharmacy adopts regulations to set forth requirements, limitations, and prohibitions for pharmacists and pharmacies who participate in or perform functions for central prescription processing. The rule is effective May 16, 2009. Contact: Margaret Clifford; Board of Pharmacy; (603-271-2350)

New Jersey Prescription Blanks - Proposed rule of the Department of Law and Public Safety, Division of Consumer Affairs, would amend regulations regarding the use of uniform New Jersey prescription blanks (NJPBs) by licensed prescribers, health care facilities, and pharmacies. The proposal would require all NJPBs to be preprinted with consecutive or serialized numbers and be preprinted with the prescriber or healthcare facility National Provider Identifier (NPI) number if one has been obtained. The proposal also would allow a licensed prescriber affiliated with a licensed healthcare facility to use the NJPB of the facility under certain conditions and exempt a prescriber if a verbal or electronic prescription is transmitted and the prescriber's NPI number is also provided. In addition, the proposal would allow for the termination of approved vendors from the NJPB for ''inability to comply'' with program requirements. Finally, the proposal would require vendors to maintain an on-site computerized database of relevant information for licensed prescribers and healthcare facilities.

Comments are due Sept. 4, 2009. Contact: David Szuchman; DLPS, Division of Consumer Affairs;

Controlled Substances - Final rule of the Department of Health and Human Services amends regulations to add lisdexamfetamine as a stimulant to Schedule II. The rule also adds embutramide as a depressant and buprenorphine as a narcotic drug to Schedule III. The rule conforms to federal Drug Enforcement Administration changes. The rule is effective June 1, 2009. Contact: DHHS; (919-715-4168)

Destruction of Dangerous Drugs - Proposed rule of the State Board of Pharmacy would amend regulations under concerning the destruction of dispensed drugs and disposal of stock prescription drugs. The proposal would clarify that only dangerous drugs that have been previously dispensed to a patient may be accepted by a pharmacy and destroyed. Comments are due July 31, 2009. Contact: Allison Benz; SBP; (512-305-8028).

Controlled Substances - Notice of the Department of State Health Services announces an amendment to the schedules of controlled substances to place the substance tapentadol into Schedule II and lacosamide into Schedule V. The action is effective July 23, 2009. Contact: DOH;

Charitable Clinic Pharmacies - Final rule of the Board of Pharmacy adopts regulations regarding charitable clinic pharmacies. The rule defines terms and addresses provisions concerning requirements of a pharmacist-in-charge and the operation, required permits, limitations, and inspections and investigation of pharmacies classified as charitable clinic pharmacies. The rule also establishes standards for the receipt of sample drugs by such pharmacies. The rule is effective July 1, 2009. Contact: Board of Pharmacy; (304-558-0558)

Dispensing and Administration of Drugs/Automated Devices - Notice of the Department of Health Professions, Board of Pharmacy, announces a decision to grant a petition for rulemaking requesting that the board amend regulations regarding the practice of pharmacy. The petition requests that the board revise provisions pertaining to automated devices for dispensing and administration of drugs to use the activity reports rather than having a nurse or other licensed person sign for the delivery. The agency intends to publish a notice of intended regulatory action soliciting comment on the proposal. Contact: Elizabeth Russell; DHP, Board of Pharmacy; (804-662-9911).