Board News and Announcements
WEDNESDAY, JUNE 12, 2019
USP COMPOUNDING CHAPTER UPDATES
United States Pharmacopeia (USP) has published the chapter revisions for USP <795> and <797>, for non-sterile and sterile compounding. USP also published the newly developed chapter <825> on Radiopharmaceuticals. These chapters along with USP Chapter <800> Handling of Hazardous Drugs will become enforceable for compounding operations on December 1, 2019. USP has made USP Chapters <797>, <797>, <800>, and <825> available free to download at http://go.usp.org/l/323321/2019-05-31/2dfgwl. Board Staff will be posting guidance documents about the updated USP Chapters and also will be posting our updated inspection forms with the updates incorporated.
In the meantime, USP has developed very detailed FAQs on all four chapters.
USP <800>: https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings
USP <825>: https://www.usp.org/frequently-asked-questions/radiopharmaceuticals
With respect to USP Chapter <800> and non-compounding activities involving hazardous medications pharmacists are reminded that the Board’s position is as follows:
NC Board of Pharmacy's position with respect to USP <800> standards and their application to non-compounding activities involving hazardous medications
The NC Board of Pharmacy views compliance with USP <800> as a best practice for pharmacies who are doing non-compounding activities with hazardous medications. As pharmacists know, USP Chapter <800> standards are designed to protect pharmacists, pharmacy staff, patients, and the public from the harmful effects of exposure to hazardous medications.
As USP Chapter <800> standards for non-compounding activities become commonly followed, North Carolina law is likely to reflect that doing so is considered standard of practice. In that case, failure to comply may be evidence of negligence. Therefore, you are encouraged to evaluate (and to continue to re-evaluate) to what extent compliance reflects the appropriate standard of care. Board staff will continue to make observations during inspections to help identify potential risk for handling Hazardous Medications, and will provide education on how to comply with USP Chapter <800> standards to minimize risk to pharmacy staff, patients, and the public. These observations regarding USP Chapter <800> compliance in non-compounding activities involving Hazardous Medications will not, by themselves, serve as a basis for disciplinary action by the Board. The Board's full position statement may be found here: http://www.ncbop.org/PDF/BoardPositionStatementforUSP800UPDATEDMarch2019.pdf.
Board Staff have created helpful educational information that addresses identification of Hazardous Drugs, instructions on conducting an Assessment of Risk, and templates for non-compounding pharmacies to develop Standard Operating Procedures (SOPs) addressed in USP<800>. This informational material is for pharmacies that DO NOT compound with hazardous medications: http://www.ncbop.org/PDF/USP800PacketforNonCompoundingPharmaciesUPDATEDMarch2019.pdf.
As a reminder Board issued a statement on September 29, 2017 statement regarding, pharmacies that perform any nonsterile or sterile compounding with Hazardous Medications must be in full compliance with USP <800> when the chapter becomes official December 1, 2019 in accordance to NCAC 46. 2801. That position statement may be found here: http://www.ncbop.org/PDF/NCBOP_USP_800_Statement.pdf.
FRIDAY, MAY 31, 2019
2019 BOARD ELECTION - SEPTEMBER CANDIDATE INFORMATION SESSIONS
As noted here in greater detail, the next North Carolina Board of Pharmacy elections are scheduled to begin November 1, 2019. Two district seats will be up for election this year: the Central District and the Northeastern District.
Board staff will host two question-and-answer sessions in September. Anyone interested in learning more about Board service and the election process should plan to attend one of these sessions:
- Raleigh (Northeastern District) Tuesday, September 10, 2019 at 7:00PM at the McKimmon Center on the campus of NC State University.
- Asheboro (Central District) Tuesday, September 24, 2019 at 7:00PM at the Hampton Inn Asheboro.
Please contact Jay Campbell with any questions.
MONDAY, APRIL 22, 2019
ATLAS PHARMACEUTICAL ANNOUNCES RECALL OF MISBRANDED LOTS OF COMPOUNDED METRONIDAZOLE MINI TABS FOR VETERINARY CLINICS. Veterinary clinics are directed to this information concerning a recall of compounded veterinary products: http://www.ncbop.org/PDF/AtlasPharmaceuticalsVolRecallMetronidazole041119.pdf.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JUNE 12, 2019.)
FRIDAY, MARCH 1, 2019
FDA AND NORTH CAROLINA DEPARTMENT OF AGRICULTURE EMPHASIZE THAT CBD-CONTAINING SUPPLEMENTS ARE NOT LAWFUL UNDER THE FEDERAL AND NORTH CAROLINA FOOD DRUG & COSMETIC ACTS. On December 20, 2018, FDA Commissioner Scott Gottlieb issued a statement explaining that while the Farm Bill of 2018 removed hemp from the federal Controlled Substances Act, "Congress explicitly preserved the [FDA's] authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act." Hence, the FDA "treat[s] products containing cannabis or cannabis-derived compounds as [it does] any other FDA-regulated products." Importantly, FDA reminded the regulated community that it is "unlawful under the FD&C Act . . . to market CBD or THC products as, or in, dietary supplements, regardless or whether the substances are hemp derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as . . . dietary supplements." The full text of Commissioner Gottlieb's statement may be found here: http://www.ncbop.org/pdf/FDACannabisStatement122018.pdf.
In late February, the North Carolina Department of Agriculture -- which directly regulates industrial hemp products in North Carolina -- began sending letters to businesses that manufacture or sell CBD-containing products emphasizing that "North Carolina has routinely adopted by reference the federal Food, Drug & Cosmetic Act and implementing regulations. The violation of these federal laws and regulations would equally be a violation of state laws and regulations." The Department of Agriculture's letter -- like Commissioner Gottlieb's statement -- emphasizes that "CBD is the active ingredient in the approved drug product Epidiolex" and that "[s]ince CBD is the active ingredient in the approved drug product Epidiolex, it is currently excluded from being a dietary supplement under section 210(ff)(3)(B)(i) and (ii) of the FD&C Act."
The North Carolina Department of Agriculture further emphasized that "CBD products marketed with claims to prevent, mitigate, diagnose, treat or cure diseases" make those products "drugs under the FD&C Act." Accordingly, "CBD in products other than the approved drug Epidiolex and which make health claims would be a new drug that cannot legally be introduced into interstate commerce."
The full text of the Department of Agriculture letter is found here: http://www.ncbop.org/pdf/CBDletterNCDeptAgriculture.pdf.
Board staff trusts this clears up any lingering confusion concerning CBD-containing supplements.
FRIDAY, MARCH 1, 2019
TWO NEW BOARD RULES EFFECTIVE MARCH 1, 2019.
Two amendments to Board rules went into effect on March 1, 2019:
First, an amendment to 21 NCAC 46.2403 added over-the-counter nicotine replacement therapies to the formulary of drugs and devices that registered nurses in local health department clinics may dispense.
Second, an amendment to 21 NCAC 46.2502 adds a new exception to the general rule that a pharmacist may only serve as pharmacist-manager at one pharmacy. A pharmacist may serve simultaneously as pharmacist-manager at two full-service pharmacies if one of the two is a newly permitted pharmacy that has not yet begun providing pharmacy services to patients. The pharmacist-manager may serve in this dual capacity until the newly permitted pharmacy begins providing pharmacy services to patients or six months from the issuance of the new pharmacy permit, whichever comes first. At that point, the pharmacist must relinquish the earlier pharmacist-manager position and may only serve as pharmacist-manager at the newly permitted pharmacy.
WEDNESDAY, FEBRUARY 27, 2019
Board Requirements on Submitting Drug Disaster & Loss Report, Incident Reports, and Drug Disposal Forms
Since August 2017, in an ongoing effort to increase efficiency and to provide the most secure platform possible, the NC Board of Pharmacy transitioned to a new online licensing/enforcement system. It grants access to printable documents, change of address, online applications and many more features. This also includes Drug Disaster and Loss Reports, Drug Disposal Forms, and Incident Reports.
Drug Disaster & Loss Reports, Incident Reports, and Drug Disposal Forms must be submitted by pharmacist manager or designated permit personnel through the Licensure Gateway. Board staff no longer accepts faxed notifications of potential medication loss; DEA 106 forms; and Drug Disaster & Loss Reports, Incident Reports or Drug Disposal Forms submitted by fax, email, or USPS mail.
A reminder to all pharmacist managers/pharmacists in charge on statutes and rules pertaining to these reports:
- Drug Disaster and Loss Reports - NCGS 90-85.25(B) states that “the pharmacist in charge of a pharmacy shall report within 10 days to the Board any disaster, accident, theft, or emergency which may affect the strength, purity, labeling of drugs and devices in the pharmacy”.
- Incident Reports - 21 NCAC 46.2502(l) states that “The pharmacist-manager shall report to the Board of Pharmacy information that reasonably suggests that there is a probability that a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient or customer. This report shall be filed in writing on a form provided by the Board within 14 days of the owner representative or pharmacist-manager's becoming aware of the event. The pharmacist-manager shall retain all documents, labels, vials, supplies, substances and internal investigative reports relating to the event. All such items shall be made available to the Board upon request”.
- Drug Disposal Forms – 21 NCAC 46.3001(a) states that “All registrants under G.S. 90-85.21 shall develop and implement policies and procedures to insure that all out-dated, improperly labeled, adulterated, damaged or unwanted drugs or drug containers with worn, illegible or missing labels are destroyed or disposed of so as to render them unusable.”
WEDNESDAY, FEBRUARY 13, 2019 - NCBOP MEETING DATE CHANGE
Please note that the NC Board of Pharmacy's June meeting has been changed to Tuesday, June 11, 2019 and will begin at 10:00am.
MONDAY, FEBRUARY 11, 2019
FDA STEPS UP ENFORCEMENT ACTIVITIES AGAINST MAKERS OF “DIETARY SUPPLEMENTS” THAT MAKE UNSUBSTANTIATED CLAIMS REGARDING DISEASE TREATMENT AND/OR CONTAIN PRODUCTS THAT HAVE BEEN APPROVED AS DRUGS. In recent weeks, the FDA has stated its intent to step up enforcement activities against people and entities marketing “dietary supplements” in a way that, in fact, makes those supplements adulterated and misbranded drugs. Last week, the FDA followed through and issued a number of warning letters, including one to an outfit based in Blowing Rock, NC marketing “colloidal silver” products. FDA’s recent actions are a reminder to pharmacists of their legal and professional responsibilities to sell and counsel on dietary supplements in a way strictly compliant with federal regulation and with the patient’s health and well-being. More information here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm
FRIDAY, JANUARY 4, 2019
FDA STATEMENT CONCERNING CBD PRODUCTS AFTER PASSAGE OF THE FARM BILL. A number of pharmacists have inquired about the status of CBD-containing products after passage of the Farm Bill late last month. On December 20, 2018, FDA Commissioner Scott Gottlieb issued a statement about what the Farm Bill changed – and, as importantly, did not change – when it comes to CBD products: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm.
*REMINDER* DEA POSITION ON TRANSFER OF "ON FILE" CONTROLLED SUBSTANCE PRESCRIPTIONS
Pharmacists continue to call Board staff with understandable confusion on whether and how “on file” controlled substance prescriptions that were never filled may be transferred. To recap:
In April 2017, word began swirling that DEA viewed transfers of “on file” controlled substances as not allowed. On July 7, 2017, Loren Miller, Associate Section Chief, Liaison and Policy Section, Diversion Control Division, Drug Enforcement Administration sent an email to Carmen Catizone, Executive Director of the National Association of Boards of Pharmacy, setting forth DEA’s view on the matter.
In that email (found here -- http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf), Mr. Miller states the view that 21 CFR 1306.25 allows a pharmacy, “once it has filled an original prescription for a controlled substance in Schedule III-V,” to “transfer the original prescription information to another DEA registered pharmacy for the purposes of allowing that second pharmacy to then dispense any remaining valid refills . . . .” Mr. Miller further stated that “an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered pharmacy.”
Mr. Miller then stated that, based on “the preamble” of an “interim final rule,” it is DEA’s “policy” that an electronic prescription for a controlled substance of any schedule may be “forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy” even if that prescription had not been filled.
To say that DEA’s positions in this matter create a mess is a gross understatement. First, while Mr. Miller’s reading of 21 CFR 1306.25 is textually plausible, it represents a departure from decades of standard pharmacy practice and there has been no suggestion from DEA or anyone else that the standard practice of transferring “on file” but unfilled (as opposed to once-filled) controlled substance prescriptions has caused or materially contributed to controlled substance abuse or misuse. Second, neither Mr. Miller’s email nor any language in the preamble he references contains so much as a hint as to what an appropriate mechanism for “forwarding” (and documenting the forwarding of) an unfilled electronic controlled substance prescription would be. Third, Mr. Miller’s email does not explain why “forwarding” an unfilled electronic controlled substance prescription is substantively different than transferring an unfilled controlled substance prescription, whether electronic, verbal, or written. Fourth, DEA’s position creates not only an incentive, but a practical necessity, for patients seeking to change their pharmacy of choice to obtain duplicate controlled substance prescriptions from their caregiver. Interpretations and policies that guarantee duplicate prescriptions for controlled substances in multiple pharmacies hardly seems consistent with the Controlled Substance Act’s purpose to create a controlled, closed distribution system and minimize controlled substance abuse and misuse.
All that said, however, DEA has shown no inclination to reconsider or clarify these positions. Where does that leave us?
(1) Though “forwarding” of unfilled electronic controlled substance prescriptions is available by “policy,” the lack of any guidance from DEA on how a “forwarding” should occur and be documented means that most pharmacies and pharmacists are reluctant to entertain the practice. And who can blame them?
(2) For unfilled verbal prescriptions for a Schedule III-V controlled substances, DEA’s position means that there is no mechanism for moving them from one pharmacy to another.
(3) For unfilled paper prescriptions for a Schedule III-V controlled substances, a pharmacy could return the original to the patient to physically carry to another pharmacy. Board staff understand completely the practical problems of this approach.
Some pharmacists have inquired why Board staff, the Board, or the North Carolina legislature have taken this position. As the above makes clear, none of the three are to blame. The present state of affairs is attributable solely, and entirely, to the DEA. Board staff will, of course, update pharmacists if the DEA sees reason and backs away from these positions. Until then, send your cards, letters, and calls to the DEA.
THURSDAY, FEBRUARY 22, 2018
OPIOID PUBLIC SERVICE ANNOUNCEMENT CAMPAIGN - ADS AVAILABLE FOR DOWNLOAD
Beginning February 8, 2018, the Board of Pharmacy opened an opioid public service announcement campaign on Wilmington and Greenville-area television stations and on social media platforms. The advertisements feature Joe Adams, a pharmacist and past president of the National Association of Boards of Pharmacy, sharing his deeply personal story of losing his son to an opioid overdose in 2014. These ads emphasize the important of obtaining help and the critical role pharmacists can play.
The ads come in 30-second, 60-second, and 6-minute versions, and are available for download here. Board members and staff welcome and encourage pharmacists using these ads to educate their patients and communities about proper medication use and the dangers of opioid abuse.
The Board thanks Third Wheel Media of Chapel Hill and the National Association of Boards of Pharmacy (NABP) for their tremendous efforts on this issue. Pharmacists will note that texting “abuse” to 555888, as instructed in the ads, will result in a reply text providing a link to an NABP-created and hosted page containing resources for pharmacists to share with patients and their communities. That page may be accessed directly here: https://nabp.pharmacy/homepage/prescription-drug-safety/.
These ads are the first phase of a multi-media campaign. Board staff will continue to keep pharmacists updated as the campaign progresses.
Please contact Board staff at 919.246.1050 with questions.
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The North Carolina Board of Pharmacy's mission is to protect the public health, safety and welfare in pharmaceutical matters. The Board sets standards for academic and practical experience programs prior to licensure, issues permits to operate pharmacies and DME facilities, and annually renews licenses, permits and registrations.
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