Revision: Jan. 16, 2019, 8:39 a.m.
HB 615 - AS INTRODUCED
2019 SESSION
19-0672
10/01
HOUSE BILL 615
AN ACT relative to the regulation of pharmacies and pharmacists.
SPONSORS: Rep. Merchant, Sull. 4
COMMITTEE: Executive Departments and Administration
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ANALYSIS
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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
19-0672
10/01
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Nineteen
AN ACT relative to the regulation of pharmacies and pharmacists.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 New Paragraph; Pharmacy; Definitions; Aseptic Technique. Amend RSA 318:1 by inserting after paragraph I-a the following new paragraph:
I-b. “Aseptic Technique” means a set of specific practices and procedures performed with the goal of minimizing contamination by pathogens or viable microbes.
2 Pharmacy Board. Amend RSA 318:5, I to read as follows:
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.
3 New Paragraph; Rulemaking. Amend RSA 318:5-a by inserting after paragraph XIX the following new paragraph:
XX. The standards and procedures for licensure of virtual manufacturers, virtual distributors, brokers, and third party logistics providers.
4 Application Fee for Pharmacist License. Amend RSA 318:23 to read as follows:
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.
5 Renewal of License. Amend RSA 318:25 to read as follows:
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] Biennially, in even-numbered years, reapply for licensure [as of January 1] 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.
6 Impersonating an Applicant. Amend RSA 318:20 to read as follows:
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.
7 New Subparagraph; Dealing in or Possessing Prescription Drugs; Dental Hygienists. Amend RSA 318:42, II by inserting after subparagraph (b) the following new subparagraph:
(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).
8 Dealing in or Possessing Prescription Drugs; Registered Nurse, Physician Assistant. Amend RSA 318:42, VIII to read as follows:
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 medications using aseptic technique 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.
9 Misconduct; Violations. Amend RSA 318:29, II(g) to read as follows:
(g) [Willful or repeated] Violation of any provision of this chapter, any substantive rule of the board, or any other federal, state, or local drug or pharmacy-related law, rule, or regulation.
10 Impaired Pharmacist Program; Biennial License. Amend RSA 318:29-a, VI(b) to read as follows:
(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).
11 Pharmacy Permit Renewal. Amend RSA 318:38, II to read as follows:
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.
12 Renewal; License of Manufacturers and Wholesalers. Amend RSA 318:51-a, I to read as follows:
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.
13 Renewal; License for Limited Retail Drug Distributors. Amend RSA 318:51-b, I to read as follows:
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.
14 Renewal; License of Outsourcing Facilities. Amend RSA 318:51-c, I to read as follows:
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.
15 Renewal; License of Research Organizations. Amend RSA 318:51-f, I to read as follows:
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.
16 New Section; Drug Distribution Agents. Amend RSA 318 by inserting after section 51-f the following new section:
318:51-g Licensure of Drug Distribution Agents, including Prescription Drug Virtual Manufacturers, Virtual Distributors, Jobbers, Brokers, and Third Party Logistics Companies.
I. No person shall act as a prescription drug distribution agent, which includes companies acting as virtual manufacturers, virtual distributors, jobbers, brokers, or third party logistics companies involved in the distribution of prescription drugs, or controlled drugs as defined in RSA 318-B:1, VI, without first having obtained a license from the board. Such license shall expire biennially on November 30 of each even-numbered year. An online renewal together with a reasonable fee as established by the board shall be filed biennially on or before November 30 of every even-numbered year.
II. No license shall be issued under this section unless the applicant has furnished proof satisfactory to the board of pharmacy:
(a) That the applicant is of good moral character or, if that applicant is an association or corporation, that the managing officers are of good moral character.
(b) That the applicant has sufficient land, buildings, and such security equipment to properly carry on the business described in the application.
III. No license shall be granted to any person who has within 5 years been convicted of a violation of any law of the United States, or of any state, relating to drugs, as defined in this chapter or RSA 318-B, or to any person who is a drug-dependent person.
IV. Any person licensed pursuant to this section is subject to the provisions of RSA 318:29.
V(a). The prescription drug distribution agent, virtual manufacturer, virtual distributor, jobber, broker, or third party logistics (3PL) company to which a license has been issued shall, within 30 days of any change of information supplied in the original application, notify the board.
(b) The notice required pursuant to subparagraph (a) shall contain:
(1) Current New Hampshire license number of the prescription drug distribution agent, virtual manufacturer, virtual distributor, jobber, broker, or third party logistics (3PL) company.
(2) Name of the prescription drug distribution agent, virtual manufacturer, virtual distributor, jobber, broker, or third party logistics (3PL) company, old and new, if applicable.
(3) Address of the prescription drug distribution agent, virtual manufacturer, virtual distributor, jobber, broker, or third party logistics (3PL) company, old and new, if applicable.
(4) Names, addresses, and titles of new corporate officers, partners, or owners.
(c) A new license shall be required for a change of ownership of an established prescription drug distribution agent, virtual manufacturer, virtual distributor, jobber, broker, or third party logistics (3PL) company to a successor business entity which results in a change in the controlling interest in the company.
17 Pharmacy; Civil Penalties. Amend RSA 318:55, II to read as follows:
II. In addition to the penalties under paragraph I, the board may impose a civil penalty not to exceed $5,000 per violation upon any person who [willfully or repeatedly] violates any provision of this chapter.
18 Repeals. The following are repealed:
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.
19 Effective Date. This act shall take effect 60 days after its passage.