Oklahoma 2023 Regular Session

Oklahoma Senate Bill SB765 Compare Versions

Version 1 (Old)

Version 2 (New)

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29		-	SENATE FLOOR VERSION
30		-	March 2, 2023
	53	+	STATE OF OKLAHOMA
31	54
	55	+	1st Session of the 59th Legislature (2023)
32	56
33		-	SENATE BILL ~~NO.~~ 765 By: Standridge
	57	+	SENATE BILL 765 By: Standridge
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	63	+	AS INTRODUCED
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39	65		An Act relating to the practice of pharma cy; defining
40	66		terms; requiring wholesale distributors to make
41	67		adequate provisions for the return of certain
42	68		outdated prescription drugs ; requiring wholesale
43	69		distributors to establish certain written policy;
44	70		stating criteria of policy; providing exemption;
45	71		providing eligibility criteria for drugs; requiring
46	72		prompt full credit to purchaser; requiring certain
47	73		notification and documentation; requiring wholesale
48	74		distributors to maintain certain records; prohibiting
49	75		submission of drugs under certain conditions;
50	76		providing for disciplinary action; requiring
51	77		compliance with applicable laws, rules, and
52	78		regulations; amending 59 O.S. 2021, Section 353.24 ,
53	79		which relates to unlawful acts; creating exception;
54	80		updating statutory language; providing for
55	81		codification; and providing an effective date .
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61	87		BE IT ENACTED BY THE PEOPLE OF T HE STATE OF OKLAHOMA:
62	88		SECTION 1. NEW LAW A new section of law to be codified
63	89		in the Oklahoma Statutes as Section 355.5 of Title 59, unless there
64	90		is created a duplication in numbering, reads as fol lows:
65	91		A. As used in this section :
66	92		1. “Full credit” means a cash refund or credit with t he drug
67	93		wholesale distributor for the purchase price of the drug as
68		-	established by drug invoice less a reasonable fee for handling of
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	145	+	established by drug invoice less a reasonable fee for handling of
96	146		the returned drugs. A reasonable fee shall not be more than seven
97	147		percent (7%) of the total invoice price of the returned drugs ; and
98	148		2. “Reverse drug distributor” means a firm, whether located
99	149		inside or outside this state, that receives drugs for destruction,
100	150		return credit, or otherwise disposes of drugs received from a
101	151		registrant located in this state who holds a permit or license to
102	152		dispense or possess drugs . As used in this paragraph, “registrant”
103	153		means a person registered by the Director of the Oklahoma State
104	154		Bureau of Narcotics and Dangerous Drugs Control under Section 2-302
105	155		of Title 63 of the Oklahoma Statutes.
106	156		B. Effective with all drug orders placed on or after the
107	157		effective date of this act, all wholesale distributors shall make
108	158		adequate provisions for the return of outdated pre scription drugs,
109	159		both full and partial containers, for up to six (6) months after the
110	160		labeled expiration date for prompt full credit.
111	161		C. Wholesale distributors shall establish a written policy
112	162		providing for the return of outdated prescription drugs sold t o a
113	163		client by such wholesale distributor. Such policy may include a
114	164		procedure for the drugs to be returned to the drug manufac turer, may
115	165		include a requirement that the drugs be returned in the original
116	166		containers in which they were purchased, and may include the use of
117	167		a reverse drug distribut or. Such policy shall be available to the
118	168		State Board of Pharmacy or its agents upon reque st.
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146	220		D. Influenza vaccines shall be exempt from the requirements of
147	221		this provision if they have an expiration date of less th an one year
148	222		from the date such drug is m anufactured.
149	223		E. In order to be eligible for full credit , the drug must be
150	224		received by the wholesale distributor, or if not the wholesale
151	225		distributor, its agent designa ted in its return policy, no later
152	226		than the sixth month from the labeled expiration date . A signed
153	227		delivery receipt shall constitute evidence of the drug s having been
154	228		returned.
155	229		F. Prompt full credit to the purchaser shall occur within sixty
156	230		(60) calendar days from the date the return drugs were received b y
157	231		the wholesale distributor or its d esignated agent. If the wholesale
158	232		distributor determine s that the drugs were not returned wi thin six
159	233		(6) months of the labeled expiration date, or were not returned
160	234		consistent with the written return policy, then the wh olesale
161	235		distributor shall notify the purchaser in writing within thirty (30)
162	236		calendar days of the receipt of the drugs of it s intent not to give
163	237		full credit. Wholesale distributors shall maintain d ocumentation
164	238		supporting their refusal to give full credit for a period of two (2)
165	239		years. Such documentation shall be available to the Board or its
166	240		agent upon request.
167	241		G. Wholesale distributors shall maintain records of all credits
168	242		made under this section for a period of two (2) years and such
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196	294		record shall be made available to the Board or its agent upon
197	295		request.
198	296		H. The submission of drugs by a purchaser licensed by the Boar d
199	297		in this state for refund or credit to a wholesale distributor
200	298		pursuant to this section when the drugs are in a container other
201	299		than the one in which they were purchased, when the drugs were not
202	300		purchased from that wholesale distributor, or when th e drugs were
203	301		purchased for a pharmacy or facility outside this state shall
204	302		constitute fraudulent and unprofess ional conduct and may subject the
205	303		purchaser to disciplinary action by the Board.
206	304		I. The return of drugs under this section shall comply with all
207	305		other applicable federal, state, and local laws, rules, and
208	306		regulations.
209	307		SECTION 2. AMENDATORY 59 O.S. 2021, Section 353.24, is
210	308		amended to read as follows:
211	309		Section 353.24. A. It shall be unlawful for any licensee or
212	310		other person to:
213	311		1. Forge or increase the quantity of drug in any prescription,
214	312		or to present a prescription bearing forged, fictitious o r altered
215	313		information or to possess any drug secured by such forged,
216	314		fictitious or altered prescription;
217	315		2. Sell, offer for sale, barter or give a way any unused
218	316		quantity of drugs obtained by prescription, except through a program
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246	368		pursuant to the Utilizati on of Unused Prescription Medications Act
247	369		or as otherwise provided by the State Board of Pharmacy;
248	370		3. Sell, offer for sale, barter or give away an y drugs damaged
249	371		by fire, water, or other causes without first obtaining the written
250	372		approval of the Board or the State Department of Health;
251	373		4. No person, firm or business establishment shall offer to the
252	374		public, in any manner, their services as a “pick-up station” or
253	375		intermediary for the purpose of having prescriptions filled or
254	376		delivered, whether for profit or gratuitously. Nor may the owner of
255	377		any pharmacy or drug store authorize any person, firm or business
256	378		establishment to act for them in this manner with these exceptions:
257	379		a. patient-specific filled prescriptions may be delivered
258	380		or shipped to a prescriber ’s clinic for pick-up by
259	381		those patients whom the prescriber has i ndividually
260	382		determined and documented do not have a permanent or
261	383		secure mailing address,
262	384		b. patient-specific filled prescriptions for drugs which
263	385		require special handling written by a prescrib er may
264	386		be delivered or shipped to the prescriber’s clinic for
265	387		administration or pick-up at the prescriber ’s office,
266	388		c. patient-specific filled pres criptions, including
267	389		sterile compounded drugs, may be delivered or shipped
268	390		to a prescriber’s clinic where they shall be
269	391		administered,
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297	443		d. patient-specific filled prescriptions for patients
298	444		with end-stage renal disease (ESRD) may be delivered
299	445		or shipped to a prescriber ’s clinic for administration
300	446		or final delivery to the patient,
301	447		e. patient-specific filled prescriptions for
302	448		radiopharmaceuticals may be delivered or shipped to a
303	449		prescriber’s clinic for administration or pick -up, or
304	450		f. patient-specific filled prescriptions may be delivered
305	451		or shipped by an Indian Health Services Service (IHS)
306	452		or federally recognized tribal health organization
307	453		operating under the IHS in the delivery of the
308	454		prescriptions to a pharmacy operated by the IHS or a
309	455		federally recognized tribal health organization for
310	456		pick-up by an IHS or tribal patient.
311	457		However, nothing in this paragrap h shall prevent a pharmacist or
312	458		an employee of the pharmacy from personally recei ving a prescription
313	459		or delivering a legally filled prescrip tion to a residence, office
314	460		or place of employment of the patient for whom the prescription was
315	461		written. Provided f urther, the provisions of this paragraph shall
316	462		not apply to any Department of Men tal Health and Substance Abuse
317	463		Services employee or any per son whose facility contracts with the
318	464		Department of Mental Health and Substance Abuse Services whose
319	465		possession of any dangerous drug, as defined in Section 353.1 of
320	466		this title, is for the purpose of delivery of a mental health
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348	518		consumer’s medicine to the consumer’s home or residence. Nothing in
349	519		this paragraph shall prevent veterinary prescription drugs from
350	520		being shipped directly from an Oklahoma licensed wholesaler or
351	521		distributor registered with t he Oklahoma State Board of Veterinary
352	522		Medical Examiners to a clie nt; provided, such drugs may be dispensed
353	523		only on prescription of a licensed veterinarian and only when an
354	524		existing veterinary-client-patient relationship exists. Nothing in
355	525		this paragraph shall prevent dialysate and peritoneal dialysis
356	526		devices from being shipped directly from an Oklahoma licensed
357	527		manufacturer, wholesaler or distributor to an ESRD patient or
358	528		patient’s designee, consistent with subsection F of Section 353.18
359	529		of this title;
360	530		5. Sell, offer for sale or barter or buy any professional
361	531		samples except through a program pursuant to the Utilization of
362	532		Unused Prescription Medications Act;
363	533		6. Refuse to permit o r otherwise prevent members of the Board
364	534		or such representatives thereof from entering and inspecting any and
365	535		all places, including premises, vehicles, equipment, contents, and
366	536		records, where drugs, medicine, chemicals or poisons are stored,
367	537		sold, vended, given away, compounded, dispensed, repackaged,
368	538		transported, or manufactured;
369	539		7. Interfere, refuse to participate in, impede or otherwise
370	540		obstruct any inspection, investigation or disciplinary proceeding
371	541		authorized by the Oklahoma Pharmacy Act;
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399	593		8. Possess dangerous drugs wi thout a valid prescription or a
400	594		valid license to possess such drugs; provided, however, this
401	595		provision shall not apply to a ny Department of Mental Health and
402	596		Substance Abuse Services employee or any person whose facility
403	597		contracts with the Department of Me ntal Health and Substance Abuse
404	598		Services whose possession of any dangerous drug, as defined in
405	599		Section 353.1 of this title, is for the purpose of delivery of a
406	600		mental health consumer ’s medicine to the consumer ’s home or
407	601		residence;
408	602		9. Fail to establish and maintain effective controls against
409	603		the diversion of drugs for any other purpose than legitimate
410	604		medical, scientific or in dustrial uses as provided by state, federal
411	605		and local law;
412	606		10. Fail to have a written drug diversion detectio n and
413	607		prevention policy;
414	608		11. Possess, sell, offer for sale, barter or give away any
415	609		quantity of dangerous drugs not listed as a scheduled drug pu rsuant
416	610		to Sections 2-201 through 2-212 of Title 63 of the Oklahoma Statutes
417	611		when obtained by prescription bea ring forged, fictitious or altered
418	612		information.
419	613		a. A first violation of this section shall constitute a
420	614		misdemeanor and upon conviction shall be pu nishable by
421	615		imprisonment in the county jail for a term not more
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449	667		than one (1) year and a fine in an amount no t more
450	668		than One Thousand Dollars ($1,000.00).
451	669		b. A second violation of this section shall constitute a
452	670		felony and upon conviction shall be punishabl e by
453	671		imprisonment in the Department of Corrections for a
454	672		term not exceeding five (5) years and a fine in an
455	673		amount not more than Two Thousand Dollars ($2,000.00);
456	674		12. Violate a Board order or agreed order;
457	675		13. Compromise the security of licensure examina tion materials;
458	676		or
459	677		14. Fail to notify the Board, in writing, within ten (10) days
460	678		of a licensee or perm it holder’s address change.
461	679		B. 1. It shall be unlawful for any person o ther than a
462	680		licensed pharmacist or physician to certify a prescription before
463	681		delivery to the patient or the patient ’s representative or
464	682		caregiver. Dialysate and peritoneal dialysis devices supplied
465	683		pursuant to the provisions of subsection F of Section 35 3.18 of this
466	684		title shall not be required to be certified by a pharmacist prior to
467	685		being supplied by a manufacturer, wholesaler or distributor.
468	686		2. It shall be unlawful for any perso n to institute or manage a
469	687		pharmacy unless such person is a licensed pharma cist or has placed a
470	688		licensed pharmacist in charge of such pharmacy.
471	689		3. No licensed pharmacist shall manage, supervise or be in
472	690		charge of more than one pharmacy.
473	691
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475		-	(Bold face denotes Committee Amendments) 1
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500	742		4. No pharmacist being requested to sell, furnis h or compound
501	743		any drug, medicine, chemical o r other pharmaceutical preparation, by
502	744		prescription or otherwise, shall substit ute or cause to be
503	745		substituted for it, without authority of the prescriber or
504	746		purchaser, any like dr ug, medicine, chemical or pharmac eutical
505	747		preparation.
506	748		5. No pharmacy, pharma cist-in-charge or other person shall
507	749		permit the practice of pharmacy except by a licensed pharmacist or
508	750		assistant pharmacist.
509	751		6. No person shall subvert the authority of the ph armacist-in-
510	752		charge of the pharmacy by impeding the management of the
511	753		prescription department to act in compliance with federal and state
512	754		law.
513	755		C. 1. It Except as provided by Section 1 of this act, it shall
514	756		be unlawful for a:
515	757		1. A pharmacy to resell dangerous drugs to any wholesale
516	758		distributor.
517	759		2. It shall be unlawful for a; or
518	760		2. A wholesale distributor to purchase drugs from a pharmacy.
519	761		SECTION 3. This act shall become effective November 1, 202 3.
520		-	~~COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES~~
521		-	~~March 2,~~ 2023 ~~- DO PASS~~
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