Revision: March 14, 2019, 1:52 p.m.
HB 615 - AS AMENDED BY THE HOUSE
HOUSE BILL 615
SPONSORS: Rep. Merchant, Sull. 4
COMMITTEE: Executive Departments and Administration
This bill makes various changes to the regulation of pharmacies and pharmacists by the board of pharmacy, including procedures of the board, exceptions to possessing prescription drugs, license expirations and renewals, and establishing the licensure of drug distribution agents.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
14Mar2019... 0773h 19-0672
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Nineteen
Be it Enacted by the Senate and House of Representatives in General Court convened:
I. The board shall have a president, vice-president, and a secretary, [and a treasurer] who shall be elected from among their number annually in the month of September.
XX. The standards and procedures for licensure of drug or device distribution agents.
318:20 Impersonating Applicant.
I. No one shall impersonate an applicant before the board of pharmacy applying for licensure under the provisions of this chapter.
II. No third party shall sign an application, complete an application, call to check on the status of an application, or submit an application and documentation on behalf of an applicant.
III. No third party shall complete an online renewal, paper renewal, or make any changes or updates to an original application on behalf of an applicant.
IV. Authorization and release forms shall not be accepted as a form of release.
318:23 Application Fee for Pharmacist License. Each person applying for a license to practice the profession of pharmacy in this state by way of examination shall pay a reasonable application fee to be established by the pharmacy board. This fee shall include the cost of [standard examination forms, the cost of administering the examination, and the cost of] investigating the applicant's qualifications to become a pharmacist in this state.
318:25 [Relicensure] Renewal of License. Pharmacist licenses shall expire [annually] biennially in even-numbered years at midnight on December 31. Every licensed pharmacist who wishes to continue to practice the profession of pharmacy shall:
I. [Annually reapply for licensure as of January 1] Biennially, in even-numbered years, apply for license renewal no later than midnight on December 31;
II. Pay a reasonable fee established by the board;
III. Satisfy any continuing education requirements established by the board; and
IV. Provide such data relating to his practice, residence, and status as deemed necessary by the board.
(b) The board may allocate an amount determined by the board from each pharmacist [annual] biennial license renewal fee it collects to provide funding for the impaired pharmacist program as set forth in subparagraph VI(a).
II. All pharmacy permits shall expire when there is a change of ownership of the pharmacy or at midnight on December 31 [of each] biennially in each odd-numbered year. Every pharmacy that wishes to continue to operate as such shall renew its permit [annually as of January 1] no later than December 15 biennially in odd-numbered years or immediately when the permit expires for any other reason. It shall be deemed a violation of the provisions of this chapter for any pharmacy to be open or operated beyond the expiration date of its permit.
(c) Nothing in this section shall prohibit a dental hygienist from possessing, administering, dispensing, or prescribing of a fluoride supplement, topically applied fluoride, and chlorhexidine gluconate oral rinse pursuant to RSA 317-A:21-c, I(g).
VIII. A registered nurse or physician assistant from:
(a) Making dilutions from concentrated solutions or pre-weighed or pre-measured packets.
(b) Adding prepared sterile additives.
(c) Reconstituting or diluting medications following manufacturers specific directions.
(d) Entering an institutional pharmacy in an institutional setting specially designated for this purpose by the institution in the absence of a pharmacist to obtain those drugs needed in an emergency situation.
I. No person shall manufacture legend drugs or controlled drugs as that term is defined in RSA 318-B:1, VI and no person as a wholesaler, distributor, or reverse distributor shall supply the same without first having obtained a license to do so from the board. Such license shall expire [annually] biennially on June 30 of every even-numbered year. An application together with a reasonable fee as established by the board shall be filed [annually on or before July 1] biennially by midnight on June 30 of every even-numbered year.
I. No person shall operate as a limited retail drug distributor, as defined in RSA 318:1, VII-a, without first having obtained a license to do so from the board. Such license shall expire [annually] biennially on June 30 of each odd-numbered year. An application together with a reasonable fee as established by the board shall be filed [annually on or before July 1] biennially by midnight June 15 of every odd-numbered year.
I. No person shall compound legend drugs or controlled drugs, as defined in RSA 318-B:1, VI, and no person acting as or employed by an outsourcing facility shall supply such drugs, without first having obtained a license from the board. Such license shall expire [annually] biennially on June 30 of each odd-numbered year. An application together with a fee established by the board shall be filed [annually on or before July 1] biennially by June 15 of every odd-numbered year.
I. No research organization shall procure or conduct research operations with prescription drugs by researchers without first having obtained a license from the board. Such license shall expire [annually] biennially on June 30 of each odd-numbered year. An application together with a reasonable fee as established by the board shall be filed [annually on or before July 1] biennially by June 15 of every odd-numbered year.
318:51-g Licensure of Drug or Device Distribution Agents.
I. No person shall act as a prescription drug or device distribution agent, which includes controlled drugs as the term is defined in RSA 318-B:1, VI, without first having obtained a license to do so from the board.
II. Any person licensed pursuant to this section shall be subject to the provisions of RSA 318:29.
III. For purposes of this section:
(a) A drug or device distribution agent shall include virtual manufacturers, virtual wholesaler distributors, jobbers or brokers (including sales/marketing offices), and third-party logistics companies, and any other agent involved in the handling or distribution of prescription drugs, medical gases, or prescription medical devices or equipment in the supply chain that affects the pedigree of the products.
(b) “Broker or jobber” is any party that mediates between a buyer and a seller for the sale or shipment of prescription drugs, gases, equipment or devices.
(c) "Pedigree" is a document or an electronic file containing information that records each distribution of any given prescription drug, medical gas, or prescription medical device or equipment.
(d) “Third-party logistics provider” is a person that contracts with a wholesale distributor or a manufacturer to provide or coordinate warehousing, wholesale distribution, or other services on behalf of a manufacturer, but does not take title to the prescription drug, gas, device or equipment.
(e) “Virtual manufacturer” is anyone that owns the NDA or ANDA for a prescription drug, gas, device or equipment that contracts with others for the actual manufacturing.
(f) “Virtual wholesale distributor” is anyone engaged in wholesale distribution of prescription drugs, gases, devices or equipment.
I. RSA 318:45, relative to certain sales permitted.
II. RSA 318:46 and 318:47, relative to keeping and inspection of a record book.
III. RSA 318:47-e, relative to procedures for dispensing emergency contraception.
IV. RSA 318:51-a, V(b)(4), relative notification by manufacturers and wholesalers of corporate changes.