Frequently Asked Questions Concerning Free or Charitable Pharmacy Clinics
Q: Do I need a pharmacy permit to operate a free or charitable clinic?
A: Yes. North Carolina law defines a pharmacy as “any place where prescription drugs are dispensed or compounded.” N.C.G.S. § 90-85.3(q). There is no exception to the permitting requirement for clinics that operate on a free or charitable basis.
Q: Do I need a pharmacy permit to distribute prescription drug samples?
A: The federal Prescription Drug Marketing Act (“PDMA”) prohibits a pharmacy from receiving or dispensing sample medications. A free or charitable clinic, however, may provide samples of prescription drugs to patients so long as the samples are obtained in conformance with the PDMA and are provided to the patient under the direct supervision of the physician charged by the PDMA with responsibility for appropriate receipt and disbursement of prescription drug samples.
Donated Prescription Drugs/Sample Prescription Drugs
A: Pursuant to Board policy issued in June 2003, permit holders may dispose of unwanted prescription drugs that are not controlled substances by transferring products in unit dose or bingo cards, not to be resold, to other permit holders which are “free” or charitable clinics in a voluntary written agreement which allows for record keeping and other expenses.
Q: Can pharmacists accept donations of prescription drugs from individuals?
Q: Can pharmaceutical manufacturers donate prescription drug samples to free or charitable clinics?
Copies of the guidance may be obtained at: http://www.fda.gov/cder/guidance/5519fnl.pdf
Q: Can I charge a fee or ask for a donation for medications acquired through Medication Assistance Programs (MAP)?
A: The North Carolina Board of Pharmacy does not regulate the financial aspects of any MAP. Questions concerning whether and under what circumstances free or charitable clinics may charge a fee for dispensing medications acquired through a MAP should be directed towards the companies or organizations that supervise them, or to counsel retained by the free or charitable clinic.
Dispensing Physicians, Physician Assistants, Nurse Practitioners
Q: Can a physician dispense prescription drugs at a free or charitable clinic?
A: Physicians who dispense drugs for a fee or other charge (dispensing physicians) must annually register with the Board. See N.C.G.S. § 90-85.21(b). The annual registration fee is $75.00. A dispensing physician must comply with all of the laws governing the practice of pharmacy, including appropriate packaging, labeling, recordkeeping, and patient counseling.
Dispensing physicians should be aware that referring their Medicare or Medicaid patients to their internal dispensaries could put them at risk of violating Medicare/Medicaid fraud and abuse laws.
Q: May physician assistants and nurse practitioners dispense prescription drugs from a free or charitable clinic?
A: 21 N.C.A.C. 46.1703 (“Rule .1703”) provides:
21 NCAC 46 .1706 (“Rule .1706”) provides:
Q: If a nurse practitioner or physician assistant at the free or charitable clinic dispenses only sample prescription drugs, must he/she register with the Board as a dispenser?
A: The Board does not interpret Rule .1703’s requirements to apply to a PA or NP who is engaged in traditional sampling – i.e., handing out, free of any charge (whether direct or indirect), starter doses or packets of prescription drug samples received from a prescription drug manufacturer in compliance with the Prescription Drug Marketing Act.
Q: May free or charitable clinics mail medications to patients?
A: Nothing in the Pharmacy Practice Act or associated rules prohibits a licensed in-state free or charitable clinics from mailing medications to patients that reside in North Carolina and can do so as long as all regulations are met for in-state pharmacies. In particular, mailing does not excuse the free or charitable clinic from its patient counseling obligations.
Q: Must pharmacy technicians who work at free or charitable clinics register with the Board?
A: Yes. For several years, a Board guidance statement advised that volunteer pharmacy technicians providing services at a facility designated as a free or charitable clinic were required to undergo statutorily-prescribed training, but need not register with the Board. A recent case has prompted the Board to rescind this guidance statement. As a result, all pharmacy technicians practicing in any pharmacy setting – including free or charitable clinics – must be registered with the Board of Pharmacy. Such registration must occur by the close of the 2015 renewal period, February 28, 2015. Detailed background and other information may be found here: http://www.ncbop.org/faqs/Board_Policy_Concerning_Technicians_at_Free_Charitable_Clinics_Oct2014.pdf.
Q: What are the training requirements for pharmacy technicians?
A: N.C.G.S. § 90-85.15A(b) provides that it is the responsibility of the pharmacist manager to provide training for all technicians. The training is not limited to, but must contain training in at least the following areas:
This training must be completed within 180 days of the technician’s beginning work at the free or charitable clinic.
Q: Can I request a Board audit of my free or charitable clinic?
A: The North Carolina Board of Pharmacy does not perform audits to make operational recommendations to pharmacies. If any pharmacy would like to be inspected for compliance with North Carolina law, the pharmacist manager should send a written request to the Board.
Controlled Substance Issues
Q: Does a free or charitable clinic require a Drug Enforcement Agency registration for dispensing, storing, or administering controlled substances?
A: Yes. A DEA number is required by any pharmacy that orders, stores, or dispenses any controlled substances. The statue describing who must register with the DEA can be found here: http://www.usdoj.gov/dea/pubs/csa/822.htm
A list containing many controlled substances can be found at the DEA’s web site at the following address: http://www.usdoj.gov/dea/pubs/scheduling.html
The DEA new application form can be found here: http://www.deadiversion.usdoj.gov/drugreg/index.html
Q: Can I receive any continuing education credit for volunteer work at a free or charitable clinic?
A: At the July 1999 meeting of the Board, and revised at the January 2008 meeting, the members approved one contact hour of continuing education (CE) credit for every three hours of volunteer practice at a free or charitable clinic, with a maximum of five contact hours per year. If a pharmacist is subjected to a CE audit, it will be the responsibility of the pharmacist-manager at the clinic to certify the hours worked and credit issued.
Glossary of Terms
Certified technician. 21 NCAC 46 .1317 (5) A technician who has passed a pharmacy technician certification board exam, or its equivalent, that has been approved by the Board according to the rules in this Chapter.
Consulting pharmacist. 21 NCAC 46 .1317 (6) A licensed pharmacist who, in collaboration with the supervising physician and nurse practitioner or assistant to the physician, develops a retrospective drug utilization review program which:
Counseling. 21 NCAC 46 .2504 The effective communication of information to the patient or representative in order to improve therapeutic outcomes by maximizing proper use of prescription medications, devices, and medical equipment. Specific areas of patient counseling include, but are not limited to, those matters that in the exercise of the pharmacist's or device and medical equipment permit holder's professional judgment are considered significant:
DEA number. A number issued by the United States Drug Enforcement Agency to a registrant, which shall include anyone who prescribes, stores, ships, manufactures, or dispenses a controlled substance
Dispense. N.C.G.S. § 90-85.3 (f) Preparing and packaging a prescription drug or device in a container and labeling the container with information required by State and federal law. Filling or refilling drug containers with prescription drugs for subsequent use by a patient is "dispensing". Providing quantities of unit dose prescription drugs for subsequent administration is "dispensing".
Health Care Facility Pharmacy. 21 NCAC 46 .1317 (15) A pharmacy maintained in a hospital, clinic, nursing home, rest home, sanitarium, non-federal governmental institution, industrial health facility, or other like health service under the supervision of a pharmacist; or the central area in a hospital, clinic, or other health care facility where drugs are procured, stored, processed, or issued, or where pharmaceutical services are performed.
License. N.C.G.S. § 90-85.3 (l) A license to practice pharmacy including a renewal license issued by the Board.
Limited service permit. 21 NCAC 46 .1317 (18) A pharmacy permit issued by the Board to an applicant that wishes to render in an institutional setting pharmaceutical services not limited to scope and kind but to time and conditions under which such services are rendered.
Permit. N.C.G.S. § 90-85.3 (m) A permit to operate a pharmacy, deliver medical equipment, or dispense devices, including a renewal license issued by the Board.
Q: Can prescription drug samples be donated to free clinics?
A: FDA published the following text in the March 14, 2006 edition of the Federal Register:
FDA is announcing the availability of a guidance for industry entitled "Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics." The guidance provides information for free clinics that receive donated prescription drug samples from licensed practitioners or other charitable institutions. The guidance discusses concerns that have been expressed by certain individuals regarding regulatory requirements for drug sample donations. The guidance announces that FDA, after reviewing an independent study report analyzing the potential effects of the regulations on free clinics, has decided to propose revisions to those regulations. In the interim, FDA intends to exercise its enforcement discretion and does not intend to object if a free clinic fails to comply with certain regulatory requirements for drug sample donations.
Copies of the guidance may be obtained at: http://www.fda.gov/cder/guidance/5519fnl.pdf