Board News and Announcements
TUESDAY, AUGUST 26, 2014
UPDATE: BOARD OF PHARMACY ISSUES GUIDANCE ON THE REPORTING OF FLU VACCINE ADMINISTRATION TO THE IMMUNIZATION REGISTRY. Board staff have received a number of inquiries whether administration of an influenza vaccine must be reported to the North Carolina Immunization Registry. The answer is no. NCGS 90-85.15B(d)(3) (part of the pharmacist vaccine administration statute passed last year) previously stated that “except for influenza vaccines administered under G.S. 90-85.15B(b)(6)”, an immunizing pharmacists must “access the North Carolina Immunization Registry prior to administering the vaccine . . . and record any vaccine . . . administered to the patient in the registry within 72 hours after the administration.” The clear intent of the statute, therefore, was that influenza vaccine administrations not be reported to the Registry. Confusion rose because the referenced paragraph – G.S. 90-85.15B(b)(6) – does not exist. Rather, influenza vaccine administration is discussed in G.S. 90-85.15B(c). The mismatched cross-reference has now been corrected by the General Assembly, and the statute is now clear that influenza vaccines administered under G.S. 90-85.15B(c) do not have to be reported to the Registry.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED AUGUST 28, 2014.)
FRIDAY, AUGUST 22, 2014
DRUG ENFORCEMENT ADMINISTRATION PLACES ALL HYDROCODONE CONTAINING PRODUCTS INTO SCHEDULE II EFFECTIVE OCTOBER 6, 2014. Today, August 22, 2014, the federal Drug Enforcement Administration issued a final rule placing all hydrocodone-containing drug products into Schedule II. The rule is effective October 6, 2014. Hydrocodone-only products already were Schedule II controlled substances. This rule places all hydrocodone combination products into Schedule II. The full text of the rule, including the DEA’s response to various concerns raised about the rescheduling is found here: http://www.ncbop.org/PDF/DEAHydrocodoneCombinationProductReschedule082214.pdf.
Some questions likely to arise:
- When is the rule effective? The rule is effective October 6, 2014.
- Why did the Board of Pharmacy pass the rule? The Board of Pharmacy did not pass this rule. It is a federal rule passed by the Drug Enforcement Administration. DEA’s explanation of the rule is found at the document linked above.
- What do I need to do with my inventory of hydrocodone-containing products? Per requirements in the federal Controlled Substances Act, each DEA registrant pharmacy must conduct an inventory of all hydrocodone-containing products on October 6, 2014. Pharmacies must maintain that inventory with all other controlled substance inventory records.
- What do I do about prescriptions for hydrocodone-containing products issued prior to October 6? The DEA’s rule speaks directly to this issue: “Any prescriptions for [hydrocodone-containing products] that are issued before October 6, 2014, and authorized for refilling, may be dispensed in accordance with [with the rules governing Schedule III prescriptions] if such dispensing occurs before April 8, 2015.” In other words, any refills authorized on a pre-October 6, 2014 prescription for a hydrocodone-containing products may be dispensed in accordance with the “no more than five refills within 6 months” requirement for Schedule III products. But no refills of such prescriptions may occur after April 8, 2015.
- When do I have to start ordering hydrocodone-containing products using DEA Form 222 or CSOS? October 6, 2014.
- I have stock bottles of hydrocodone-containing products that are labeled “C III.” Do I need to relabel them? No. Manufacturers must label all hydrocodone-containing products “C II” by October 6, 2014. Neither pharmacists nor manufacturers are required to relabel stock bottles distributed prior to October 6, 2014.
- Does this affect North Carolina’s identification requirement for dispensing controlled substances? No. North Carolina’s controlled substance identification statute already requires that an identification be obtained prior to dispensing any Schedule II controlled substance, and for certain Schedule III controlled substances. Hydrocodone-containing products were among the Schedule III controlled substances for which an identification had to be obtained. More information about the controlled substance identification statute may be found here: http://www.ncbop.org/faqs/PhotoIDFAQ.pdf
- Will hydrocodone-containing product prescriptions have a six-month expiration date under North Carolina law? Yes. More information concerning that statute, which went into effect October 1, 2013, may be found here: http://www.ncbop.org/faqs/Pharmacist/faq_SchIIControlledSub.htm
MONDAY, AUGUST 18, 2014
TRAMADOL CONTAINING PRODUCTS ARE A SCHEDULE IV CONTROLLED SUBSTANCE EFFECTIVE TODAY, AUGUST 18, 2014. Pharmacists are reminded that today, August 18, 2014, tramadol containing products became a Schedule IV controlled substance. Pharmacies are required to conduct an inventory of all tramadol products today and to maintain that inventory with other controlled substance inventory records. Several pharmacists have inquired about the status of tramadol prescriptions issued before today, but which are either more than six months old, have been refilled five or more times, or both. DEA has not been entirely clear on this point. Board staff is advising pharmacists that the safe approach is, if you have a tramadol prescription that has already been refilled five times within 6 months, then obtain a new prescription from the prescriber.
WEDNESDAY, JULY 30, 2014
UNIQUE PHARMACEUTICALS HAS RECALLED ALL STERILE COMPOUNDED PREPARATIONS DUE TO LACK OF STERILITY ASSURANCE. Unique Pharmaceuticals, Ltd, of Temple, TX, has announced a voluntary recall of all sterile drug preparations compounded by the outsourcing facility. The company initiated the recall due to FDA concerns regarding Unique’s compounding facilities and processes following recent inspections, according to a Unique Pharmaceuticals press release announcing the recall. Products recalled include all sterile compounded preparations that the company has supplied to its customers within expiry, distributed nationwide in syringes, vials, and bags. Nonsterile preparations are unaffected by the recall. Unique is notifying customers by phone, fax, mail, or personal visits and providing additional instructions for the recall. To date, there have been no reports of injury or illness associated with the use of these products. Adverse actions related to the use of this product may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The FDA’s announcement may be found here: http://www.fda.gov/Safety/Recalls/ucm405938.htm
TUESDAY, JULY 15, 2014
BOARD OF PHARMACY ISSUES GUIDANCE ON THE PERMITTING OF “OUTSOURCING FACILITIES”
Board staff has received inquiries concerning whether and under what circumstances a Section 503B outsourcing facility (as defined in the federal Drug Quality and Security Act) must also hold a pharmacy permit. The answer depends on the scope of services provided at the facility. The following guidance issued by the Board of Pharmacy on July 15, 2014 details the circumstances under which Section 503B outsourcing facilities must obtain (or maintain) a pharmacy permit: http://www.ncbop.org/PDF/GuidancePermittingOutsourcingFacilities071514.pdf.
MONDAY, JULY 14, 2014
The NC Board of Pharmacy’s monthly meetings will now be live-streamed via YouTube. Follow this link - http://www.ncbop.org/calendar.htm - to access a calendar of 2014-15 Board meeting dates. Meetings begin at 9:00am.
To watch live, at the start of the meeting go to https://www.youtube.com/ and in the search box at the top, type in the month, year, and “NC Board of Pharmacy meeting.” So for the July meeting, you would search under “July 2014 NC Board of Pharmacy meeting.”
TUESDAY, JULY 8, 2014
DRUG ENFORCEMENT AGENCY ISSUES FINAL RULE PLACING TRAMADOL INTO SCHEDULE IV. On July 2, 2014, the DEA issued its final rule placing tramadol into Schedule IV. Tramadol becomes a Schedule IV controlled substance effective August 18, 2014. Accordingly, pharmacies must take an inventory of all stocks of tramadol on hand as of August 18, 2014 and maintain that inventory with other controlled substance inventory records. The full text of DEA’s notice may be found here: http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0702.htm
THURSDAY, JULY 3, 2014
FOOD AND DRUG ADMINISTRATION RELEASES ADDITIONAL GUIDANCE CONCERNING IMPLEMENTATION OF THE DRUG QUALITY AND SECURITY ACT. On Tuesday, July 1, 2014, the federal Food and Drug Administration released additional guidance concerning implementation of the Drug Quality and Security Act, including: (1) draft interim guidance concerning CGMP compliance for Section 503B outsourcing facilities; (2) a proposed rule revising FDA’s list of drug products that may not be compounded because they have been withdrawn or removed from the market for lack of safety or efficacy; (3) final guidance to compounding pharmacies on Section 503A; and (4) notice of reopening the nomination process for lists of bulk drug substances that may be used to compound drug products. More information, including links to the various documents, may be found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403507.htm
MONDAY, JUNE 23, 2014 - COMPOUNDING RULE AMENDMENTS
NOTICE OF PUBLIC HEARING (SEPTEMBER 16, 2014) ON PROPOSED AMENDMENTS TO RULES 21 NCAC 46 .1412 AND .2801; AND PROPOSED REPEAL OF 21 NCAC 46.1810 AND .2802-.2808 - COMPOUNDING. Revisions required by the federal Drug Quality and Security Act (Public Law No. 113-54), with accompanying revisions to simplify and consolidate the Board of Pharmacy's rules governing compounding of drug preparations.
A public hearing will be held on September 16, 2014 at 9:00am at the NC Board of Pharmacy office, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.
Any person may object to the proposed amendment by attending the public hearing on September 16, 2014 and/or by submitting a written objection by 9:00am on September 16, 2014 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, e-mail email@example.com. The North Carolina Board of Pharmacy is interested in all comments pertaining to the proposed rule. All persons interested and potentially affected by the proposal are strongly encouraged to read this entire notice and make comments on the proposed rule.
If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.
• NOTICE OF TEXT/PUBLIC HEARING:
• PROPOSED RULE/AMENDMENT LANGUAGE:
Amendment: 21 NCAC 46.1412: http://www.ncbop.org/LawsRules/1412ProposedAmendCompoundingJune2014.pdf
Amendment: 21 NCAC 46.2801: http://www.ncbop.org/LawsRules/2801ProposedAmendCompoundingJune2014.pdf
Repeal: 21 NCAC 46.1810: http://www.ncbop.org/LawsRules/1810ProposedRepealCompoundingJune2014.pdf
Repeal: 21 NCAC 46.2802 - .2808: http://www.ncbop.org/LawsRules/2802_through_2808ProposedRepealCompoundingJune2014.pdf
TUESDAY, JUNE 3, 2014 - ANTI-DIVERSION EDUCATIONAL VIDEO
Pharmacists – Increase your awareness of potential red flags when filling controlled substance prescriptions. Click here to access the video - or http://youtu.be/VrBh9X7MU2Y.
NABP recently collaborated with the Anti-Diversion Industry Working Group (ADIWG) to prepare a video intended to educate pharmacists and increase their awareness of potential red flags when filling controlled substance prescriptions. This video introduces the world of diversion through the eyes of former diverters and abusers who reveal the tricks of their trade. The video illustrates that diverters and abusers can be found in every race, gender, and age group. It’s not always who you think.
The core of the video is built around three vignettes that allow the viewer to witness the interaction through the eyes and analysis of the pharmacist. Each vignette dives deep into the interaction of pharmacists and diverters as they face each other across the counter during a transaction. During this encounter the video highlights the red flags the pharmacist must recognize in order to fulfill the pharmacist’s corresponding responsibility to prevent diversion.
The pharmacist identifies and clarifies the most critical warning signs of diversion about to take place. These red flags are highlighted through the pharmacist’s internal dialogue and on screen graphics. Some are self-evident, others not so clear. Often several of these warning signs are presented around a single prescription. The video reflects these realities as it illuminates 11 red flag behaviors.
Watch the 12-minute video here: http://youtu.be/VrBh9X7MU2Y.
FRIDAY, DECEMBER 6, 2013
FEDERAL DRUG QUALITY AND SECURITY ACT BRINGING CHANGES TO COMPOUNDING PHARMACY REGULATION. On November 27, 2013, the President signed into law the Drug Quality and Security Act (DQSA). DQSA focuses on two broad issues: (1) further refinement of the state and federal roles in regulating compounding pharmacy practices; and (2) creation and implementation of a national “track and trace” program intended to ensure integrity of the prescription drug supply chain. Compounding pharmacists undoubtedly have questions about the impact of this statute on their practices. Board staff will continue to provide information as available. Earlier this week, FDA issued guidance on the new statute. Compounding pharmacists are strongly advised to read FDA guidance. It may be found here:
- Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)
- Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)
FDA Compounding Statement: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm
Health Advisories (last updated July 30, 2014) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated December 2013) - Check here regularly for the latest updates regarding Medicare/Medicaid.
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.
For more information, please see About the NCBOP.
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