Wednesday, January 3, 2018

High Importance from the Oklahoma Board of Pharmacy

From the Inspector’s Desk ♦ 18.01. Nonsterile Compounding: A retail pharmacy may no longer provide any nonsterile compounds to physicians for “office use.” ♦ 18.02. CDS Invoices: When receiving controlled dangerous substances (CDS) from the wholesale distributor, the person checking in the drugs must either circle the quantity received for each drug, place a check mark by the quantity received for each drug, or make a notation that all drugs were received. ♦ 18.03. Compounding in Anticipation of a Prescription: Per Drug Enforcement Administration (DEA), a retail pharmacy cannot prepare in anticipation more than a 30- day supply of a compounded preparation containing a CDS. ♦ 18.04. CDS Prescriptions: In Oklahoma, a physician cannot issue multiple prescriptions to a patient for the same drug. DEA allows this, but the Oklahoma Bureau of Narcotics and Dangerous Drugs does not have a corresponding law or rule that allows it in Oklahoma. It is illegal for a prescriber to postdate a prescription. All CDS prescriptions must be dated and signed on the day when issued. If a prescriber does not want the patient to fill it that day, then he or she can put instructions on the prescription as to the date when it can be filled. The date to be filled should not exceed 30 days from the date written for Schedule II prescriptions. ♦ 18.05. BUDs for Nonsterile Compounded Preparations: For water-containing or aqueous-based topical/dermal and mucosal liquid and semisolid formations, the beyond-use date (BUD) may not exceed 30 days. For aqueous-based oral formulations, the BUD may not be longer than 14 days when stored under refrigeration. Even when you add an active pharmaceutical ingredient (API) to a commercial  product that has an aqueous component, the BUD should not exceed 14 days when refrigerated. For non-aqueous formulations, the BUD may not exceed the earliest expiration date of any API or six months, whichever is earlier. Watch the expiration dates for all ingredients used, including inactive ingredients. The BUD cannot exceed the expiration date of any ingredient used in compounding the preparation. The USP standards listed above may be exceeded when there is supporting scientific stability information that is directly applicable to the specific preparation (eg, the same drug, same brands, concentration range, pH, excipients, vehicle, water content). ♦ 18.06. Topical Compounds in Syringes Labeled “For Oral Use”: Please do not dispense topical compounded products in syringes labeled “for oral use” unless you have covered or removed the words “for oral use.” The Board has received reports of patients receiving topical medications by mouth, particularly when the person administering the medication is not the same as the person who received counseling on the prescription. ♦ 18.07. BUD for Repackaged Drugs: Food and Drug Administration (FDA) recently released a repackaging guidance that changes the acceptable expiration date for repackaged medications. The guidance applies to FDAregistered repackaging firms that are repackaging solid oral dosage forms into unit-dose containers. It does not apply to solid oral dosage forms repackaged by state-licensed pharmacies, nor to other dosage forms (sterile, liquid, or topical). Retail and hospital pharmacies that repackage into unit dose for use within their own hospital are exempt and may continue to use a one-year expiration date or the manufacturer’s expiration date, if it is less than one year. ♦ 18.08. CBD Oil: According to the Oklahoma Bureau of Narcotics, cannabidiol (CBD) oil with any detectable amount of delta-9 tetrahydrocannabinol (THC) is not legal to sell. It is extremely difficult, if not impossible, to remove all THC from a natural source of CBD oil. Synthetic CBD oil is permitted if there is no detectable quantity of THC. The Board recommends that if a pharmacy chooses to sell CBD oil, the pharmacy should obtain a certificate of analysis or have the product independently tested for the presence and quantity of THC. There have been many reports of products that have purported to contain no THC, but have tested otherwise. Pharmacies dispensing CBD products containing no more than 0.3% THC must be enrolled in an FDA-approved clinical trial. In order for a person aged 18 years or younger to receive CBD containing no more than 0.3% THC, he or she must either be participating in a clinical trial or receive a written certification from a physician licensed in this state as having been diagnosed with Lennox-Gaustaut syndrome; Dravet syndrome, also known as severe myoclonic epilepsy of infancy, or any other severe form of epilepsy that is not adequately treated by traditional therapies; spasticity due to multiple sclerosis or paraplegia; intractable nausea and vomiting; or appetite stimulation with chronic wasting diseases. The CBD must be delivered to the patient in the form of a liquid. Pursuant to Oklahoma Statutes Title 63, Section 2-101, industrial hemp from the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a THC concentration of not more than three-tenths of one percent (0.3%) on a dry weight basis shall not be grown anywhere in the state of Oklahoma but may be shipped to Oklahoma. ♦ 18.09. Clarification of Transferring “On-Hold” CDS Prescriptions: DEA has issued a statement allowing pharmacies to transfer “on-hold” Schedule II-V electronic prescriptions from one pharmacy to another if they had not been filled at the original pharmacy. However, DEA requires the transfer to be done electronically, and the electronic prescriptions for controlled substances (EPCS) software does not permit pharmacies to transmit prescriptions from one pharmacy to another. Fax transmittal is not considered to be electronic transmission. If software is changed to accommodate the requirements of EPCS, then “on-hold” CDS prescriptions may be transferred between pharmacies. DEA does not permit pharmacies to transfer “on-hold” CDS prescriptions that have been received by any other means of communication, including facsimile, verbal, or written. These requirements do not apply to the transfer of refills of CDS prescriptions. Refills may be transferred as per Oklahoma Administrative Code 535:15-3-12 and 535:15- 3-12.1.

quoted from the January 2018 Oklahoma Board of Pharmacy Newsletter
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