Pharmacy law is not generally an area of common pursuit, or concern, for the average pharmacist practicing in community pharmacy. Unfortunately, community pharmacists are increasingly cited and/or fined in greater numbers than ever, or worse, charged by the California attorney general or the Board of Pharmacy (BOP) for more severe violations of law and/or practice standards in the form of an accusation, the administrative equivalent to a civil “complaint.” This article presents a review of three pharmacy practice scenarios that encompasses: 1) Who may sign for delivery of a drug order; 2) Why to avoid overfilling prescription stock bottles; and 3) Filling out-of-state and foreign prescriptions. These scenarios are presented as an aid to meet the expectations of the BOP and to avoid problems with a BOP inspection.

This law review discusses three pharmacy practice scenarios where problems are often confronted. These situations include: 1) Who may sign for delivery of a drug order; 2) Why to avoid overfilling prescription drug stock bottles only to save shelf space; and 3) What concerns arise in the context of prescriptions written by out of state and foreign prescribers. The authors’ goal is to summarize the best practices in each situation to facilitate pharmacists’ ability to meet Board of Pharmacy (BOP) expectations and avoid issues that could arise in a BOP inspection.1 

Board inspectors routinely evaluate pharmacy processes for receiving and checking in deliveries from drug wholesalers. Far too often, pharmacies and pharmacists are cited in this situation because a pharmacy technician or a clerk has signed-off on the wholesaler’s invoice for prescription drug deliveries. California law provides that dangerous drugs or devices delivered to a pharmacy may only be ordered, signed for and received by a pharmacist.2  Additionally, the law specifies that an intern pharmacist may “perform all functions of a pharmacist, at the discretion of, and under the direct supervision and control of a pharmacist.”3  Therefore, a pharmacy intern, properly acting under the direct supervision of a pharmacist, may also receive and sign for a delivery of dangerous drugs.3  No other pharmacy employee is permitted to do so. However, where the Board has issued a license to a designated representative (usually a representative–incharge) who oversees either a wholesaler or veterinary food/drug retail operation,4  that individual is authorized to sign for, and receive a drug delivery for that operation.1,4  Designation as representative-in-charge carries responsibilities equal to those of a designated pharmacist-in-charge since neither a drug wholesaler nor a veterinary food/drug retail operation require the supervision of a pharmacist, though both operations are under the licensing jurisdiction of the Board of Pharmacy.6 

To summarize, California law provides that only a licensed pharmacist or a pharmacy intern may order, receive, and/or sign for a delivery of dangerous drugs or devices.2,3  Whereas, in the context of a drug wholesaler or veterinary food-animal drug retailer, a representative-in-charge or a designated representative may sign for and receive a drug delivery. 2,4,5 

Shelf space in a pharmacy is most always scarce. As a result, there is both a temptation and a practice to combine contents from different stock bottles of the same medication to conserve valuable shelf space. However, several legal issues may arise from this practice. For example, adding content from one (primary) stock bottle to another (secondary) stock bottle may result in a higher number of dosage units in the secondary bottle than what is represented on its label. A Board inspector discovering such a discrepancy between the contents of a stock bottle and its label could cite and fine the pharmacy on grounds that it is an overfill which violates several statutory codes designed to protect the consumer, including:

  • Conduct defined under California law as “prohibited acts” which includes the purchase, trade, sell, or transfer of dangerous drugs that are known or reasonably should be known to bemisbranded. (i.e. The secondary stock bottle would be deemed misbranded if it is filled beyond that described on its original label (overfilled), which no longer matches the current content of the bottle); 7,8,9 

  • Adulterated, misbranded or counterfeit drugs or drug products.8,9,10  “A drug is deemed to be misbranded if its labeling is false or misleading in any particular.” (i.e. The label on the secondary bottle is no longer an accurate description of the bottle’s current contents.)10 

  • False or misleading labeling of drugs or drug products.11  “A drug is misbranded, unless it bears a label containing “an accurate statement of the quantity of the contents in terms of… numerical count.”(i.e. The label on the secondary bottle is not “an accurate statement of the quantity of the contents in terms of the drug’s weight, measure, or numerical count.) 11 

  • Sale, delivery, possession of, or an offer to sell, any misbranded drug and/or device.1214  Under California law, “it is unlawful to sell, deliver, hold, or offer for sale any drug or device that is misbranded.” (i.e. A violation of any one of the code sections referenced above also constitutes a separate and distinct violation of HSC Section 111440.) 1214 

To illustrate potential issues relevant to the above-referenced Code sections (Cal. Bus. &Prof. Code (4169 (3); 4084; 4085(b); Cal. Health & Safety Code (111330, 111340(b), 111390, 111395, 111440)), consider the following sample scenario from the Board’s perspective. 1214 

When contents from different stock bottles are combined, and the contents of each bottle originate from a different manufacturer lot or batch, the respective lot numbers for each original source (for resulting mixture of the two) by definition will differ. Moreover, whether or not there is an overfill that occurs, the content of any bottle filled by combining stock may no longer be traceable to the original manufacturer or lot. Since the laws exist to protect the consumer, without the ability to track the origins of component ingredients, a consumer could not be adequately protected, if at all.

In one reported case, in defense to a violation alleged by the Board, the pharmacy and pharmacist asserted that extreme caution had been exercised to ensure that only bottles with the same lot numbers were combined in the above-described manner. Notably, the pharmacist also asserted the following counterarguments to the Board’s claim that a violation had indeed occurred:

  • An open stock bottle on the pharmacy shelf containing a total of 50 tablets remaining in it, with the original manufacturer’s label describing a count of 100 tablets would not be considered mislabeled, would it?

  • Pharmacies often use automated pill counters. To use a pill counter, tablets are poured into the counting machine from stock bottles, a practice that means each of stock bottles used to fill the machine may have different lot numbers for the same medication. The number of individual units in the machine’s counting chamber varies with each prescription filled, and likewise, the lot numbers in a single individual prescription filled from a counting machine may vary.

  • There is no law requiring a dispensed prescription to have a lot number displayed on the label affixed to the prescription bottle, yet one prescription may be filled with stock from two different bottles, each from same manufacturer, but with different lot numbers.

Unfortunately, these counter-arguments may be insufficient to vindicate the pharmacist, and/or pharmacy singled out for this practice, and might only provide a small amount of mitigation toward the ultimate sanction levied by the Board.

In summary, though no single regulation expressly addresses the issue of overfills per se, a careful reading of all applicable law clearly highlights that the best practice is to avoid combining contents from different stock bottles, when the contents originate from different manufacturers, lot, or batches. The authors also advise to avoid “overfilling” stock bottles, since even a cursory glance by a Board inspector at checking pharmacy stock on a shelf can easily reveal this type of objectionable practice.

Pharmacists may be reluctant to fill out-of-state prescriptions, though California law does not prohibit filling out-of-state prescriptions, whether routine (non-controlled substance), or controlled substance prescriptions.15  A routine (non-controlled substance) prescription written by an out-of-state prescriber, for a patient who is a California resident, maybe written either on the prescriber’s own prescription blank, or transmitted verbally to the California pharmacy, over the phone.16  A controlled substance prescription issued by an out-of-state prescriber, for delivery to a patient in another state, may be dispensed by a California pharmacy provided that the prescription conforms to the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.16,17  In other words, an out-of-state prescription for a controlled substance (Schedules III through V, only; not Schedule II), for delivery to a patient in another state may be filled, if the prescription is compliant with the prescriber’s state’s laws.18 

Additionally, it isn’t required for out-of-state controlled substance prescriptions to be written on California security blanks; however, out-of-state controlled substance prescriptions must be written on the form required in the state in which the prescriber practices.17  With respect to a patient, whether the patient is a California resident is neither relevant nor a pivotal inquiry. The critical information is the intended delivery location for the dispensed prescription (as well as whether it is Schedule II prescription). Accordingly, except for Schedule II substances, a California pharmacy may dispense an out-of-state controlled substance prescription and deliver it to an out-of-state resident (patient) outside the state of California.17  That is, a California pharmacy may dispense Schedule III, IV, and V controlled substance prescriptions from an out-of-state prescriber.18  Nonetheless, all Schedule II, III, and IV controlled substance prescriptions dispensed including those from out-of-state prescribers must be reported by the dispensing pharmacy to the CURES program under the California Department of Justice according to required methods.19  More recently. BOP regulations have incorporated Schedule V controlled substance prescriptions in the requirement to report to the CURES program.20 

Recall too, that a threshold requirement for an out-of-state prescriber to write controlled substance prescriptions is a DEA registration. If DEA- registered, an out-of-state prescriber may phone-in Schedule III, IV, or V prescriptions to a California pharmacy only for California residents. If the out-of-state DEA- registered prescriber is also licensed in California, they may acquire the California Security Forms used to write prescriptions for Schedule III, IV, or V controlled substance prescriptions only. An out-of-state prescriber, not licensed in California, will not be able to acquire the California Security Forms.21 

E-prescribing is yet another method by which an out-of-state prescriber can transmit prescriptions to a California pharmacy, and on behalf of a California resident, for Schedule II, III, IV, or V controlled substances, provided that both the prescriber and the California pharmacy are registered with the DEA e-prescribing system.22  Note, other forms of electronic transmissions (e.g. fax, scan, e-mail) commonly used in the past may not be used for controlled substances, and have been replaced by the federal e-prescribing mechanism, now required for all schedules of controlled substances.22 

Moreover, as of January 1, 2022, California’s Business and Professions Code (BPC) Section 688 requires most prescriptions in California to be issued in the form of an electronic data transmission, or “e-prescription.”23  Effective January 1, 2022, Section 688 also requires prescribers to have the capability to send, and pharmacists to have the capability to receive, electronic data transmission prescriptions.23  Section 688 brings major changes in the way some prescriptions are issued, received, and dispensed in California, however, 688 also includes contains multiple exceptions to the e-prescription requirements in specified situations.23  Concerns about curbing prescription drug abuse motivated the legislature’s intent to require all California prescribers to prescribe electronically, and California pharmacies to primarily receive e-prescriptions, as a means to reduce fraud and forgery of prescriptions and medication errors.

According to Business and Professions Code Section 4005 and California Code of Regulations Section 1717, California pharmacies may dispense prescriptions for Schedule III, Schedule IV, and Schedule V controlled substances from out-of-state prescribers.18  However, there is a caveat when an out-of-state prescriber writes a controlled substance prescription for a non-California resident, who may be travelling to visit California, and intends to fill that prescription in California.24  In such a case, if the controlled substance prescription is filled, it may not be dispensed directly to the out-of-state patient. Rather, once filled, the controlled substance prescription must be mailed to the patient’s out-of-state address. Interestingly, that requirement is consistent with the regulation for mail order operations under Calif. Health & Safety Code, Sec. 11164.1[a] stating:

“…a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms to the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.” 24 

That said, a prescription from a foreign country may not be filled by a California pharmacy. However, this rule does not apply to the US territories (Puerto Rico, Virgin Islands, Guam, and American Samoa). Prescriptions for a California resident that come from US territories must be verified as legitimate, and are governed by a set of rules which treat the US territories as “other states.” 24  These rules include:

A. California law defining “state” refers to the State of California, unless applied to the different parts of the U.S. In the latter case, it includes the District of Columbia and the territories.25 

B. Federal law under 4 USC, Sec. 110(d):

“The term ‘state’ includes any Territory or possession of the United States. (Major US recognized territories are Guam and the Virgin Islands are organized territories, but they are neither incorporated nor considered commonwealths. On the other hand, American Samoa is formally considered an unorganized territory, though it is self-governing under a 1967 constitution.” 25 

C. California law authorizing the Board to adopt regulations that allow pharmacies to fill legitimate prescriptions written by prescribers of other states;24  and

D. California law authorizing the filling of out-of-state prescriptions.24 

The authors have highlighted three common pharmacy practice scenarios where the Board of Pharmacy can readily identify violations. These situational discussions covered practice scenarios evoking these issues: 1) Who is authorized to sign for delivery of a drug order; 2) Why the best practice is to simply avoid overfilling prescription drug stock bottles; and 3) What are the various concerns that arise with prescriptions written by out-of-state and foreign prescribers. Focusing on these common situations, which arise in pharmacy practice, and navigating the relevant laws and regulations, aims to resolve issues before they occur, and perhaps eliminate the risk of BOP cites and fines.

1.
Weissman
FG,
Rosenberg
E,
Law Update: Avoiding Common Legal Issues Confronted in Pharmacy Practice: Evaluating Prescriptions with PRN Wording and Calling for Refills
,
Journal of Contemporary Pharmacy Practice
,
Vol. 66
,
No. 4
(
2019
); www.jcphp.com.
2.
Calif. Bus. & Prof. Code, Sec. 4059.5[a].
3.
Cal. Bus. & Prof. Code Sec. 4114.
4.
Cal. Bus. & Prof. Code Sec. 4053; Calif. Bus. & Prof. Code, Sec. 4059.5[a].
5.
Calif. Bus. & Prof. Code, Sec. 4022.5[a].
6.
Calif. Bus. & Prof. Code, Sections 4041, 4042.
7.
Calif. Bus & Prof. Code, Sec. 4169 Prohibited Acts (3).
8.
Cal. Bus. & Prof. Code Sec. 4084.
9.
Cal. Bus. & Prof. Code Sec. 4085 (b).
10.
Cal. Health & Safety Code, Sec. 111330.
11.
Cal. Health & Safety Code, Sec. 111340 (b).
12.
Cal. Health & Safety Code, Sec. 111390.
13.
Cal. Health & Safety Code, Sec. 111395.
14.
. Cal. Health & Safety Code, Sec. 111440.
15.
Title 16, Calif. Code of Regs, Sec. 1717
16.
Calif. Bus. & Prof. Code, Secs. 4040 and 4070
17.
Calif. Health & Safety Code, Sec. 11164.1 (a)(1)
18.
Calif. Health & Safety Code, Sec. 11164.1 (b); Calif. Bus. & Prof. Code, Sec. 4005 and Title 16, Calif. Code of Regs., Sec. 1717
19.
Calif. Health & Safety Code, Sections. 11164.1 (a)(2), 11165
20.
Calif. Health & Safety Code, Sec. 11164.1[b]
21.
Calif. Health & Safety Code, Sec. 11162.1; While the codes or regulations do not directly address the point that out-of-state prescribers who are not licensed in California cannot acquire the special California Security Forms, neither the California Board of Pharmacy, nor the California recognized security form printers, will authorize distribution of California Security Forms to out-of-California prescribers who are not licensed in California.
22.
Title 21, Code of Fed. Regs., Sec. 1311.100
23.
Cal. Bus. & Prof. Code Sec. 688 (Effective January 1,2022)
24.
Calif. Health & Safety Code, Sec. 11164.1[a]
25.
Calif. Bus. & Prof. Code, Secs. 21, & 4005[d]; 4 USC, Sec. 110(d) & Title 16, Calif. Code of Regs., Sec. 1717(d)